42 Research jobs in Ireland

Research Scientist - Pharma

Athlone, Leinster ThermoFisher Scientific

Posted 3 days ago

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Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Research Scientist, Pharma**
At PPD, part of Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research, our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
**Discover Impactful Work:**
The Research Scientist conducts and provides technical guidance on scientific method development and validation projects and/or other specialty technologies studies OR performs troubleshooting for own and others instruments, methods, procedures, and in writing protocols and reports. They design and execute method development/validation independently and interpret and review analytical data for self and others. They will routinely act as the technical project leader for multiple projects, provide updates, reviews and evaluates data, writes reports and protocols.
**A day in the life:**
+ Independently performs analytical method development/optimization/validation, and/or other specialty technologies studies OR method transfers for pharmaceuticals, specifically for techniques related to Physical and Chemical Characterization (for example HIAC, KF, FTIR, MFI, auto-titration)
+ Designs and executes experiments independently for self and others.
+ Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
+ Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
+ Leads analytical (procedural and instrumental) troubleshooting sessions.
+ Assists business development group in technical sales and marketing
+ Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.
+ Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
+ Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers
**Education and Experience**
+ Min. Degree or equivalent in Chemistry or similar
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
+ 8+ years experience that provides the knowledge and skills to perform the job
+ Significant industry experience within an analytical testing laboratory and GMP environment is essential
**Knowledge, Skills, Abilities**
+ Extensive technical expertise in equipment related to physical and chemical characterization of pharmaceutical products including but not limited to HIAC, KF, FTIR, MFI.
+ Ability to learn quickly and dedicate time to method/technical research into current techniques falling within physical testing team and new techniques that may be on-boarded in the future.
+ Proven experience of method development and validation
+ Ability to project management and deal with client audits
+ Ideally experience in leading CMC studies including method validation
+ Proven problem solving and troubleshooting abilities
+ Ability to independently perform root cause analysis for method investigations
+ Proven ability in technical writing skills
+ Time management and project management skills
+ Good written and oral communication skills
+ Ability to work in a collaborative work environment with a team
+ Ability to train junior staff
**Work Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
+ Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
+ Able to work upright and stationary and/or standing for typical working hours.
+ Able to lift and move objects up to 25 pounds.
+ Able to work in non-traditional work environments.
+ Able to use and learn standard office equipment and technology with proficiency.
+ May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
+ This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.

Sr Research Scientist - Pharma

Athlone, Leinster ThermoFisher Scientific

Posted 3 days ago

Job Viewed

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Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Senior Research Scientist - Pharma**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
Our GMP Lab in Athlone conducts testing for clinical programs and marketed products across all phases of drug development and this role is based in our Pharma lab.
**Discover Impactful Work:**
The Senior Research Scientist - Pharma oversees complex analytical development and/or specialty technologies projects to create new analytical methods, enhance existing methods, and transfer client-provided methods using multiple instrumentation techniques (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.). Provides technical and regulatory consulting to internal groups and clients about their programs. Provides technical guidance and mentorship to senior staff members in performing laboratory activities. Routinely acts as the technical project leader for multiple projects, interacts with clients to provide technical project updates, reviews and evaluates data, writes reports and protocols.
**A day in the Life:**
+ Independently plans the best scientific approach to develop analytical methods and/or other specialty technologies studies that meet client requirements.
+ Acts as on-site Subject Matter Expert (SME) for various instrumentation / technique / technology and validation/method transfer.
+ Evaluates available technical options to obtain desired quality of analytical results, economics, ease of introduction into a production environment, and robustness in analytical applications.
+ Demonstrates viability of in-house developed methods and methods transferred from clients by designing appropriate validation experiments or other appropriate aspects of specialty methodology or technology.
+ Ability to lead client discussions regarding project definitions, technical information exchanges and discussions of project status. Provides recommendations to clients on technical and regulatory issues.
+ Reviews protocols, project status reports, final study reports and other projectrelated technical documents.
+ Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.
+ Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers
**Keys to Success:**
**Education & Experience**
+ Educated to a bachelor's degree level in a relevant Scientific area, ie chemistry, biochemistry
+ 10+ years' relevant industry experience within a GMP laboratory
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills, Abilities**
+ Effective written and oral communication skills as well as presentation skills
+ Knowledge and application of industry best practices not yet represented by global regulatory requirements
+ Effective, proven experience with method development, validation and the associated regulatory and ICH requirements of same
+ Full theoretical and hands-on understanding and knowledge of general chemistry and separation science
+ Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations
+ Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
+ Ability to independently review and understand project proposals/plans
+ Proven ability in technical writing skills
+ Ability to work in a collaborative work environment with a team
+ Proven problem solving and troubleshooting abilities
+ Ability to independently optimize analytical methods
+ Time management and project management skills
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.

Advisor/Sr. Advisor - Clinical Research Scientist - Neuroscience Clinical Development: Neuropsych...

Kinsale, Munster Lilly

Posted 3 days ago

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Job Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Purpose:**
Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Clinical Research Scientist - Clinical Development: Neuropsychologist is an integral member of the Neuroscience medical development team and participates in: the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization.
The Clinical Research Scientist must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.
**Overall Responsibilities** **:**
With the expansion of the Lilly portfolio, this role will be responsible for scientific support for clinical trials across the Neuroscience platform and serves a spectrum of patients with neurological and psychiatric conditions. The clinical research scientist is a scientific resource for study teams, departments, and others as needed, particularly pertaining to the selection of clinical trial endpoints, the implementation and central monitoring strategy of clinical endpoints and the translation of clinical trial outcome data into meaningful benefits. This includes, but is not limited to, design and execution of phase 2/3 studies to address the needs of the commercial organization.
The ideal candidate will be a critical thinker and understand Neuroscience, Neuropsychology, neuropsychological assessment and measurement science.
**Specific responsibilities may include but are not limited to:**
**Clinical Planning**
+ Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design.
+ Contribute to business unit and global alignment of clinical strategy and clinical plans.
+ Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
**Clinical Research/Trial/ Execution and Support**
+ Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed upon project timeline.
+ Provide protocol oversight and input into informed consent documents.
+ Supports the monitoring of patient safety during study and participates in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
+ Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).
+ Review and collaborates with CRP on the approval of risk profiles to ensure appropriate communication of risk to study subjects.
+ Participate in investigator identification and selection, in conjunction with clinical teams.
+ Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
+ Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
+ Serve as resource to clinical operations/CTMs/ clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
+ Understand and actively address the scientific information needs of all investigators and personnel.
+ Review lIT proposals and publications, as requested by CRP or Director-Medical.
**Scientific Data Dissemination/Exchange**
+ Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals.
+ Understand and address the unsolicited scientific information needs of external health care professionals according to guidelines above.
+ Participate in reporting of clinical trial data in Clinical Trial Registry activities.
+ Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
+ Prepare or review scientific information in response to customer questions or media requests
+ Provide telephone follow-up or specific written information requested by health care professionals as per global SOPs.
+ Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis.
+ Support the design of customer research as medical expert
+ Support medical information associates in preparation and review of medical letters and other medical information materials.
+ Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).
+ Develop and maintain appropriate collaborations and relationships with relevant professional societies.
+ Support training of medical personnel, including geographic/affiliate medical personnel as assigned, medical and outcome liaisons and global patient outcomes personnel.
+ Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events)
+ Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.
**Regulatory Support Activities**
+ Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal.
+ Provide medical expertise to regulatory scientists.
+ Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.
+ Participate in advisory committees.
+ Participate in risk management planning along with affiliates and Global Patient Safety (GPS).
**Scientific I Technical Expertise and continued development**
+ Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product
+ Responsible for the scientific training of the clinical study team.
+ Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
+ Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer term (3-5 years).
+ Explore and take advantage of opportunities for extramural scientific experiences
+ Attend, contribute and participate in scientific symposia, as well as administrative/business workshops and training.
**General Responsibilities**
+ Actively set and meet individual professional development goals and contribute to the development of others.
+ Support the management team, including the Sr. Director-Medical, in preparation and administration of the business unit development budget.
+ Actively participate in recruitment, diversity and retention efforts.
+ Collaborate proactively and productively with all alliance, business and vendor partners.
+ Participate in active coaching by providing timely and constructive feedback to co-workers, others on the medical team, in the spirit of development, increased team effectiveness and cohesiveness.
+ Participate in committees, process improvement initiatives and task forces as requested by local/corporate management
+ Ensures that at all times is adequately qualified and trained in the tasks required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self.
+ Model the leadership behaviors
+ Be an ambassador of both patients and the Lilly Brand
**Basic Requirements:**
+ Doctoral level Degree (Ph.D, Psy.D or equivalent) in Clinical Neuropsychology with 2+ years industry or academic experience beyond any postdoctoral positions.
+ Demonstrated experience in clinical and/or research settings in working with adults with neurological and/or psychiatric disorders
+ Clinical experience in conducting assessments and administering standardized scales within a clinical and/or research context.
+ Experience and agility in the conduct and interpretation of statistical and psychometric analyses
+ Evidence of scientific track record in publications, conference presentations
**Additional Information:**
+ Fluent in English, written and verbal communications
+ Ability to engage in occasional domestic and international travel to the degree appropriate to support the business of the team.
+ Position Location - Indianapolis, IN or Remote
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$142,500 - $228,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
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Research analyst

Cork, Munster Pfizer Pharmaceutical

Posted today

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permanent
Company description: Use Your Power for Purpose At Pfizer, our purpose is to deliver breakthroughs that change patients lives.

Your contributions will directly impact the development of new therapies and vaccines, ultimately improving the lives of patients around the world.

By leveraging cutting-edge design and process development capabilities, you will help accelerate the delivery of best-in-class medicines to patients globally.

About Pfizer Process Development Centre The Pfizer global Process Development Centre (PDC) is an innovative team which develops new API processes and technology for the Pfizer global manufacturing network.

Additionally, the PDC leads and supports various supply assurance projects for the global manufacturing network.

Our team works closely with global research and operations teams enabling the manufacture of life saving medicines.

About the role We now have an exciting opportunity for a Research Analyst to join our team based in Cork, Ireland.

The successful candidate will work as part of a multi-disciplinary team working with leading edge technology.

The PDC is a vibrant, dynamic team with excellent career development and advancement opportunities.

This role will require attendance at our facility in Cork.

Specific Purpose Contract The purpose of this specific purpose contract is contingent upon project support requirements in PDC for the External Supply Op U Polaris initiative, which include but are not limited to the following focus areas: i) Process and Analytical development laboratory activities to support optimisation of the Isavuconazole API process and ii) Process and Analytical development laboratory activities to support the optimisation of other priority API processes identified for optimisation within the External Supply portfolio as deemed appropriate.

Job description: Job Responsibilities Apply highly specialised analytical skills to support chemical process development, pilot plant demonstrations and full-scale qualification batches as part of the Development team.

Develop, evaluate & verify analytical methods across a range of techniques as required to support projects.

Provide analytical testing across a range of techniques to support chemical process development, pilot plant demonstrations and full-scale qualification batches as part of the team.

Contribute a range of highly innovative analytical ideas to support global process development projects.

Demonstrate problem solving delivering process and analytical understanding.

Provide analytical support in technical transfer of analytical methods to manufacturing sites Co-ordinate and/or contribute to analytical validation and method transfer (MT) activities as required by project demands.

Contribute and/or lead troubleshooting and investigation of analytical issues with existing commercial API processes to support project teams, API sites (internal and external) and global technical groups.

Investigate new technologies and analytical approaches Complete reports, memos and lab notebooks experiments to a high standard and meeting required deadlines.

Contribute to the analytical team program of continuous improvement.

Ensure the ongoing safe and efficient operation of facilities.

Required profile: Requirements for all Global Job Levels Extensive knowledge and experience of analytical principles and procedures.

Practical experience in a range of analytical techniques including but not limited to HPLC, UPLC, GC, SFC, LC-MS/MS, GC-MS, KF.

A strong background in impurity isolation and identification using LC-MS to support the development and troubleshooting of chemical processes is desirable.

Experience in HPLC/UPLC method development.

GC method development experience is desirable.

Experience in p GTI method development and quantification is desirable.

Experience of method validation and method transfers, including the generation and review of MT and validation protocols and reports is desirable.

The candidate should have the ability to determine and pursue courses of action necessary to obtain desired results.

Develops advanced ideas and guides their development into a final product.

Demonstrated application of 6-sigma tools and practices and a focus on continuous improvement for work processes.

For Research Analyst, a Ph D in analytical chemistry ideally combined with 0+ years experience in the pharmaceutical industry, ideally within an analytical development role; or a BSc/MSc in a degree with significant analytical focus and ideally up to 2+ years experience in the pharmaceutical industry, ideally within an analytical development role.

Experience in project management, complex analytical investigation and method development is desired for this role.

What we offer: Work Location Assignment: On Premise How to apply Make a difference today, all suitable candidates should apply with CV below.

We are looking forward to hearing from you! ? Purpose Breakthroughs that change patients' lives.

At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence.

Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy.

We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business.

As an employer, Pfizer is committed to celebrating this, in all its forms allowing for us to be as diverse as the patients and communities we serve.

Together, we continue to build a culture that encourages, supports and empowers our employees.

Disability Inclusion Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates.

We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career.

Your journey with Pfizer starts here! Skills: analyst Research Research Analyst
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Research chemist

Cork, Munster Pfizer Pharmaceutical

Posted today

Job Viewed

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Job Description

permanent
Company description: Use Your Power for Purpose At Pfizer, our purpose is to deliver breakthroughs that change patients lives.

Your contributions will directly impact the development of new therapies and vaccines, ultimately improving the lives of patients around the world.

By leveraging cutting-edge design and process development capabilities, you will help accelerate the delivery of best-in-class medicines to patients globally.

About Pfizer Process Development Centre The Pfizer global Process Development Centre (PDC) is an innovative team which develops new API processes and technology for the Pfizer global manufacturing network.

Additionally, the PDC leads and supports various supply assurance projects for the global manufacturing network.

Our team works closely with global research and operations teams enabling the manufacture of life saving medicines.

About the role We now have an exciting opportunity for a Research Chemist to join our team based in Cork, Ireland.

The successful candidate will work as part of a multi-disciplinary team working with leading edge technology.

The PDC is a vibrant, dynamic team with excellent career development and advancement opportunities.

This role will require attendance at our facility in Cork.

Specific Purpose Contract The purpose of this specific purpose contract is contingent upon project support requirements in PDC for the External Supply Op U Polaris initiative, which include but are not limited to the following focus areas: i) Process and Analytical development laboratory activities to support optimisation of the Isavuconazole API process and ii) Process and Analytical development laboratory activities to support the optimisation of other priority API processes identified for optimisation within the External Supply portfolio as deemed appropriate.

Job description: What we offer An attractive and competitive package of pay and conditions.

Excellent opportunities for career enhancement and development.

A well-established further education programme.

Opportunity to travel to other Pfizer sites and locations.

A strong personal development programme.

About the position Reporting to the Senior Process Development Manager, the successful candidates key responsibilities, commensurate with the position are: Apply synthetic chemistry and mechanistic expertise to support commercial API processes at relevant API sites.

Apply highly specialised synthetic chemistry theoretical and process development skills to design and maintain safe, efficient, and robust processes including full-scale qualification and/or commercial validation batches meeting contemporary regulatory standards.

Contribute a range of highly innovative chemistry and process development ideas to support global process development projects.

Demonstrate problem solving delivering chemistry and process understanding.

Investigate new technologies and process development approaches to bring added value to Pfizer Global Supply.

Complete reports, memos and e LN experiments to a high standard and meeting required deadlines.

Contribute to the PDC chemistry team program of continuous improvement.

Ensure the ongoing safe and efficient operation of PDC facilities.

Required profile: The ideal candidate will possess: A minimum of a Ph D in synthetic chemistry.

Experience in the pharmaceutical industry within a process development role is desirable but not required.

Extensive knowledge and experience of synthetic chemistry and reaction mechanisms including the ability to apply knowledge to solve problems.

Knowledge of contemporary quality and regulatory guidance pertaining to the control of impurities, including potentially genotoxic impurities is desirable.

Knowledge of process development and scale-up principles, process validation and technical transfers.

Excellent practical synthetic laboratory experience and skills across a broad range of chemistries.

Background in impurity isolation and identification to support the development and troubleshooting of chemical processes.

A proven ability to plan and work independently.

The ability to determine and pursue courses of action necessary to obtain desired results; develops advanced ideas and guides their development into a final product.

Excellent written and verbal communication skills.

Positive interpersonal skills and the ability to work in a dynamic, matrix team driven environment.

Work Location Assignment: On Premise Additional Information In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.

Please note there is no relocation support available for this position What we offer: How to apply Make a difference today, all suitable candidates should apply with CV below.

We are looking forward to hearing from you! Purpose Breakthroughs that change patients' lives.

At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence.

Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy.

We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business.

As an employer, Pfizer is committed to celebrating this, in all its forms allowing for us to be as diverse as the patients and communities we serve.

Together, we continue to build a culture that encourages, supports and empowers our employees.

Disability Inclusion Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates.

We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career.

Your journey with Pfizer starts here! Skills: Research Chemist Chemist Research
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Senior Research Funding Specialist - inter- & transdisciplinary research

Dublin, Leinster Trinity College Dublin

Posted 5 days ago

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Job Description

Applications are now open for the position of Senior Research Funding Specialist (SRFS) within the Research Development Office (RDO), located in Trinity Research. The SRFS is a senior role, responsible for the design and delivery of a suite of professional supports to academic researchers and research groups, with the aim of increasing TCD participation and success in funded research programmes. The post holder will work within a central team of funding specialists, liaising closely with the wider network of research management and support professionals based in Schools and Centres, to deliver a coordinated and expert service to funding applicants. Senior Research Funding Specialists lead supports from the RDO on one or more funding programmes, managing a researcher-centred service, driving innovation in supports tailored to one or more grant types (fellowship, investigator, collaborative, commercialisation etc.) and bringing a broad disciplinary expertise to the team (e.g. health or life sciences, social sciences, arts/ humanities, physical or natural sciences etc.). Reporting to a Team Lead, the SRFS will contribute to TCD research funding success through agile leadership, teamwork and innovation in best practice supports to researchers. Note that three SRFS posts are available in the RDO at this time. Suitably qualified candidates may submit applications for more than one post. This post will have responsibility for inter- and transdisciplinary research programmes funding health research, for example through programmes such as Horizon Pillar 2 and EIC. The successful candidate will work in collaboration with RDO colleagues providing support for inter- and transdisciplinary research funding programmes. Post Status: Permanent Hours of Post: 35 hours per week Salary: Appointment will be made on the Administrative Officer 1 (1-3) €70,240 - €90,865 per annum) and in accordance with the Department of Finance guidelines. How to Apply: To assist the selection process, applicants should submit a Curriculum Vitae and a Cover Letter (maximum 1 x A4 page) that specifically addresses how their experience meets the requirements for this job. Please Note: Candidates who do not address the application requirements above in their cover letter will not be considered at the short list stage. Candidates should note that the interview process for this appointment will include the delivery of a presentation. Closing Date: 12 noon (Irish Standard Time) 16th October 2026 Application will only be accepted by applying online through the Trinity Jobs Portal must be made by the date and time specified. Any applications which are still in progress at the closing time on the specified closing date will be cancelled automatically by the system Late Applications will not be accepted. Interviews: It is intended that interviews will be held between 7th and 14th November, on the TCD campus. Skills: research or research administration national & International research funding landscap multi-sectoral engagement & facilitation IDR/ITD Horizon Pillar 2 and EIC health and healthcare research Benefits: pension
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Senior Research Consultant

Dublin, Leinster Qualtrics

Posted 3 days ago

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Job Description

At Qualtrics, we create software the world's best brands use to deliver exceptional frontline experiences, build high-performing teams, and design products people love. But we are more than a platform-we are the creators and stewards of the Experience Management category serving over 18K clients globally. Building a category takes grit, determination, and a disdain for convention-but most of all it requires close-knit, high-functioning teams with an unwavering dedication to serving our customers.
When you join one of our teams, you'll be part of a nimble group that's empowered to set aggressive goals and move fast to achieve them. Strategic risks are encouraged and complex problems are solved together, by passing the microphone and iterating until the best solution comes to light. You won't have to look to find growth opportunities-ready or not, they'll find you. From retail to government to healthcare, we're on a mission to bring humanity, connection, and empathy back to business. Join over 5,000 people across the globe who think that's work worth doing.
**Senior Advisory Consultant, Strategy & Research Services**

**Why We Have This Role**
Our Strategy & Research (S&R) Services team is a small and high-performing group of implementation, advisory, and project management professionals. We work as a unified team to help our clients master and leverage Qualtrics software, tackling complex business challenges together. Our collective success is directly tied to our clients' success, and their advocacy for our work is our ultimate measure of impact. We're looking for a proactive and commercially-minded market research consultant to join our team. We're not looking for someone to simply manage projects; we want a strategic partner for our clients and a key decision-maker on their programmes. You'll use your deep quantitative research expertise to design, deliver, and evolve research initiatives, ensuring they drive meaningful business outcomes. You'll need to be an independent contributor who thrives in ambiguity and provides clear guidance to both clients and internal teams.
**What You'll Do**
Your primary function is to serve as a trusted advisor to our clients and internal teams. You will:
+ Proactively identify and capitalise on new research opportunities, transforming client challenges into strategic solutions that drive tangible business growth and unlock new revenue streams.
+ Partner with our client management teams to ensure clients are extracting maximum value from their research programmes. This includes leading data interpretation sessions, creating concise thought pieces, and recommending new research approaches.
+ Serve as a key strategic partner in pre-sales discussions, leveraging your expertise to design bespoke research methodologies that win new business and set our clients up for long-term success.
+ Play a key advisory role during the full lifecycle of a client engagement, from initial programme design to delivering compelling insights. This includes conducting in-depth data analysis, producing professional reports, and providing insightful recommendations that enable clients to take clear action
+ Act as a change agent, guiding clients through the transition from traditional to tech-led research by confidently leading complex conversations and demonstrating the value of our innovative approach.
+ Mentor and train junior team members, setting a high bar for excellence and embodying the positive culture of our team.
+ Function as a key decision-maker on programme strategy and design, owning the execution and delivery.
**How You'll Find Success**
Success in this role is not just about delivering a project; it's about building a client relationship that convinces them of the program's value and future potential. You will find success by:
+ Demonstrating strategic thinking in all aspects of your work.
+ Thriving in an environment of ambiguity, where you are empowered to make decisions and create solutions.
+ Consistently delivering flawless results and earning your place as a trusted advisor to clients.
+ Embodying a continuous improvement and growth mindset, always seeking new and more effective ways to deliver impact.
**How You'll Grow**
+ Shape the future of our division by influencing products, processes, and deliverables.
+ Evolve into a strategic thought leader and develop unparalleled expertise within Qualtrics.
+ Mentor and train junior team members, setting a precedent for leadership and excellence.
+ Gain exposure to diverse projects and strategic initiatives that have a tremendous departmental and organizational impact.
+ Build your research expertise across different methodologies (e.g., Brand, UX, Campaign Evaluations, Pricing Studies, Concept Tests, etc.).
**What We're Looking For On Your CV**
+ A bachelor's or advanced degree in a relevant field (e.g., business, social sciences, statistics).
+ A minimum of 8 years of experience in a custom research, market research, or business analytics role, with a strong emphasis on client-facing advisory.
+ A proven track record of proactive contributions and strategic problem-solving.
+ Exceptional presentation skills, with a strong ability to translate complex data into clear, compelling narratives.
+ Experience with Qualtrics or similar research platforms is highly preferred, but not a requirement.
+ A natural ability to thrive as an independent contributor in a fast-paced, unstructured, and highly collaborative environment.
+ The flexibility to evolve in the role as needed to align with company evolution, acknowledging that we are a tech company and must always be agile.
+ Excellent written and verbal communication skills.
**What You Should Know About This Team**
+ We are a small, high-performing, and highly profitable team with a focus on strong delivery and commercial acumen.
+ Our client satisfaction rate is incredibly high, and identifying ways to continue to delight stakeholders is key to our mission.
+ We are agile and lean in across functions when and if needed-every team member is a key contributor to our collective success.
+ The day-to-day in this role is dynamic and fast-paced; the ability to prioritize and stay focused is critical to success.
**Our Team's Favourite Perks and Benefits**
+ Qualtrics Experience Program - A bonus each year for an experience of your choosing.
+ Worldwide and diverse community that enjoys helping each other.
+ We take pride in creating an open and collaborative work space.
+ At Qualtrics we are constantly working to create an environment where everyone feels safe and comfortable coming to work and can, as a result of our culture, make their best possible contribution to our team.
+ Check out more about our benefits here ( Qualtrics Hybrid Work Model:** Our hybrid work model is elegantly simple: we all gather in the office three days a week; Mondays and Thursdays, plus one day selected by your organizational leader. These purposeful in-person days in thoughtfully designed offices help us do our best work and harness the power of collaboration and innovation. For the rest of the week, work where you want, owning the integration of work and life.
_Qualtrics is an equal opportunity employer meaning that all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other protected characteristic._
_Applicants in the United States of America have rights under Federal Employment Laws: Family & Medical Leave Act ( , Equal Opportunity Employment ( , Employee Polygraph Protection Act ( is committed to the inclusion of all qualified individuals. As part of this commitment, Qualtrics will ensure that persons with disabilities are provided with reasonable accommodations. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please let your Qualtrics contact/recruiter know._
_Not finding a role that's the right fit for now? Qualtrics Insiders is the one-stop shop for all things Qualtrics Life. Sign up for exclusive access to content created with you in mind and get the scoop on what we have going on at Qualtrics - upcoming events, behind the scenes stories from the team, interview tips, hot jobs, and more. No spam - we promise! You'll hear from us two times a month max with fresh, totally tailored info - so be sure to stay connected as you explore your best role and company fit._
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Clinical Research Associate

Dublin, Leinster Grifols Shared Services North America, Inc

Posted 3 days ago

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Job Description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
**POSITION SUMMARY:**
Assist in the clinical trial management to ensure timelines and metrics are met and maintained throughout the study. Provides support in the oversight and management of vendors. Conducts review of clinical data to ensure site adherence to applicable regulatory requirements, International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, company standard operating procedures (SOPs), and study protocol.
**KEY RESPONSIBILITIES:**
+ Assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH GCP Guidelines, company SOPs, and study protocols. Ensure timelines and metrics are met and maintained throughout the study.
+ Has a good knowledge of the therapeutic area and product.
+ Obtains a complete understanding of all trial-related documents and operational procedures with moderate direct supervision
**Audits/Inspections/Quality Assurance (QA):**
+ Supports with effective and timely audit/inspection responses.
**Clinical Trial Design/Performance:**
+ Gains exposure/participates in case report form (CRF) development, interactive "X" recognition system (IXRS) set-up, central laboratory (lab) set-up, and other vendor selection processes and is capable of training others.
+ Oversees completion of Pre-Study Visits (PSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs), to determine protocol and regulatory compliance.
+ Contributes to the resolution of escalated issues from study centers, regulatory authorities and institutional review board (IRBs)/independent ethics committees (IECs) with the support of the supervisor, if needed.
+ Performs Sponsor Site Visits at selected sites to demonstrate oversight of the monitoring process and documenting the visits in the Sponsor Site Visit Report.
+ Oversees study centers to ensure timely execution of the clinical studies, generating quality data ensuring the well-being of the study subjects and the trial integrity with moderate supervision.
+ With the support from the supervisor, may support in the creation, review and tracking of study documents.
+ May assist on the TMF reviews and resolution of findings, internally or interacting with the CRO with support if needed.
**Clinical Trial Materials (CTM):**
+ Provides support on the regulatory document review and approval for investigational product (IP) release.
+ Provides support in clinical product technical complaints and product recall as necessary.
+ Provides support and information to the CTM staff regarding IP management, as needed.
**In-house Monitoring:**
+ May assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.
+ May facilitate investigator site payments, as applicable.
**Management/Training Team** :
+ Ability to facilitate meetings (e.g. Investigator Meetings, Kick-off meetings).
+ May provide support for the monitor training and contribute to resolve the issues they identified.
+ Collaborates in ensuring that appropriate training is conducted for CRO staff, vendors, investigators, and study site staff on study requirements and internal SOPs (if applicable).
**Monitoring:**
+ Reviews and tracks comments of monitoring reports generated by the vendor (i.e. CRO) as part of Sponsor Oversight of Vendor Clinical Site Monitoring activities.
+ With the support of the supervisor, if needed, verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
+ Tracks study specific tasks and progress of the trial.
+ Gets more insight, maintains and updates clinical trial management system (CTMS) information pertaining to the study.
+ Is involved in the oversight of vendor clinical monitoring activities. Ensures that the clinical monitoring process is done in adherence to an international ethical and scientific quality standard to provide public assurance that the clinical data are credible.
+ May collaborates with data management to resolve queries.
**Vendor Management:**
+ Assists in the management of vendor performance during conduct of the study with moderate direct supervision.
+ Assists in evaluation of vendor performance during conduct of the study.
+ Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation, with moderate supervision.
+ Facilitates the scheduling of internal team meetings, cooperating with defining the agenda and creating the meeting minutes, if needed.Additional On-site Monitoring Responsibilities:
**In-house Monitoring:**
+ Performs monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies.
+ Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits.
+ Reconciles clinical supplies and drug accountability records at study sites.
+ Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
+ Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required.
+ Reviews, clarifies, and obtains, data changes via query resolutions with site personnel.
+ Conducts completion of PSVs, SIVs, IMVs, and COVs, to determine protocol and regulatory compliance.
+ Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities in agreement with the Clinical Monitoring Plan for the study.
**Monitoring:**
+ Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.Safety:
+ Understands and supports implements processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes.
**PERSON SPECIFICATION**
+ Typically requires 2 years of experience in clinical research, including a minimum of 1-year field monitoring experience (e.g., independent monitoring, co-monitoring, accompanied site visits).
+ Associate's degree in a life science field required.
+ Relevant experience in clinical research and field monitoring experience preferred (e.g. independent field monitoring and co-monitoring).
+ 4 years clinical research experience with 2 years experience as a CRA
+ Bachelor's degree or higher degree in a life science field preferred.
**Our Benefits Include:**
+ Highly competitive salary
+ Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
+ Private Medical Insurance for the employee (Irish Life)
+ Ongoing opportunities for career development in a rapidly expanding work environment
+ Succession planning and internal promotions
+ Education allowance
+ Wellness activities - Social activities eg. Padel, Summer Events
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply - we're excited to hear from you
#LI-FD1
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:**
This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate

Grifols Shared Services North America, Inc

Posted 3 days ago

Job Viewed

Tap Again To Close

Job Description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
**POSITION SUMMARY:**
Assist in the clinical trial management to ensure timelines and metrics are met and maintained throughout the study. Provides support in the oversight and management of vendors. Conducts review of clinical data to ensure site adherence to applicable regulatory requirements, International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, company standard operating procedures (SOPs), and study protocol.
**KEY RESPONSIBILITIES:**
+ Assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH GCP Guidelines, company SOPs, and study protocols. Ensure timelines and metrics are met and maintained throughout the study.
+ Has a good knowledge of the therapeutic area and product.
+ Obtains a complete understanding of all trial-related documents and operational procedures with moderate direct supervision
**Audits/Inspections/Quality Assurance (QA):**
+ Supports with effective and timely audit/inspection responses.
**Clinical Trial Design/Performance:**
+ Gains exposure/participates in case report form (CRF) development, interactive "X" recognition system (IXRS) set-up, central laboratory (lab) set-up, and other vendor selection processes and is capable of training others.
+ Oversees completion of Pre-Study Visits (PSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs), to determine protocol and regulatory compliance.
+ Contributes to the resolution of escalated issues from study centers, regulatory authorities and institutional review board (IRBs)/independent ethics committees (IECs) with the support of the supervisor, if needed.
+ Performs Sponsor Site Visits at selected sites to demonstrate oversight of the monitoring process and documenting the visits in the Sponsor Site Visit Report.
+ Oversees study centers to ensure timely execution of the clinical studies, generating quality data ensuring the well-being of the study subjects and the trial integrity with moderate supervision.
+ With the support from the supervisor, may support in the creation, review and tracking of study documents.
+ May assist on the TMF reviews and resolution of findings, internally or interacting with the CRO with support if needed.
**Clinical Trial Materials (CTM):**
+ Provides support on the regulatory document review and approval for investigational product (IP) release.
+ Provides support in clinical product technical complaints and product recall as necessary.
+ Provides support and information to the CTM staff regarding IP management, as needed.
**In-house Monitoring:**
+ May assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.
+ May facilitate investigator site payments, as applicable.
**Management/Training Team** :
+ Ability to facilitate meetings (e.g. Investigator Meetings, Kick-off meetings).
+ May provide support for the monitor training and contribute to resolve the issues they identified.
+ Collaborates in ensuring that appropriate training is conducted for CRO staff, vendors, investigators, and study site staff on study requirements and internal SOPs (if applicable).
**Monitoring:**
+ Reviews and tracks comments of monitoring reports generated by the vendor (i.e. CRO) as part of Sponsor Oversight of Vendor Clinical Site Monitoring activities.
+ With the support of the supervisor, if needed, verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
+ Tracks study specific tasks and progress of the trial.
+ Gets more insight, maintains and updates clinical trial management system (CTMS) information pertaining to the study.
+ Is involved in the oversight of vendor clinical monitoring activities. Ensures that the clinical monitoring process is done in adherence to an international ethical and scientific quality standard to provide public assurance that the clinical data are credible.
+ May collaborates with data management to resolve queries.
**Vendor Management:**
+ Assists in the management of vendor performance during conduct of the study with moderate direct supervision.
+ Assists in evaluation of vendor performance during conduct of the study.
+ Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation, with moderate supervision.
+ Facilitates the scheduling of internal team meetings, cooperating with defining the agenda and creating the meeting minutes, if needed.Additional On-site Monitoring Responsibilities:
**In-house Monitoring:**
+ Performs monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies.
+ Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits.
+ Reconciles clinical supplies and drug accountability records at study sites.
+ Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
+ Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required.
+ Reviews, clarifies, and obtains, data changes via query resolutions with site personnel.
+ Conducts completion of PSVs, SIVs, IMVs, and COVs, to determine protocol and regulatory compliance.
+ Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities in agreement with the Clinical Monitoring Plan for the study.
**Monitoring:**
+ Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.Safety:
+ Understands and supports implements processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes.
**PERSON SPECIFICATION**
+ Typically requires 2 years of experience in clinical research, including a minimum of 1-year field monitoring experience (e.g., independent monitoring, co-monitoring, accompanied site visits).
+ Associate's degree in a life science field required.
+ Relevant experience in clinical research and field monitoring experience preferred (e.g. independent field monitoring and co-monitoring).
+ 4 years clinical research experience with 2 years experience as a CRA
+ Bachelor's degree or higher degree in a life science field preferred.
**Our Benefits Include:**
+ Highly competitive salary
+ Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
+ Private Medical Insurance for the employee (Irish Life)
+ Ongoing opportunities for career development in a rapidly expanding work environment
+ Succession planning and internal promotions
+ Education allowance
+ Wellness activities - Social activities eg. Padel, Summer Events
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply - we're excited to hear from you
#LI-FD1
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:**
This advertiser has chosen not to accept applicants from your region.

Open Research Librarian

Dublin, Leinster Royal College of Surgeons (RCSI)

Posted 5 days ago

Job Viewed

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Job Description

Job Title: Open Research Librarian Reporting To: Associate Librarian Education, Research & Clinical Support Location: 26 York Street School (or department): RCSI Library Contract type/duration: Permanent, Full Time Closing date for applications: 5pm, Wednesday 22nd October 2025 Royal College of Surgeons Ireland (RCSI): RCSI is a community of academic, research, clinical and professional staff working collaboratively to lead the world to better health. Here, you will thrive in an innovative and inclusive atmosphere, and your personal development and wellbeing will be supported. We invite you to join us to help deliver on our exciting mission "To educate, nurture and discover for the benefit of human health". We seek candidates whose experience to date has prepared them to contribute to our commitment to the "Race Equality Action Plan " at RCSI. Our students come from all walks of life and so do we. We hire great people from a wide variety of backgrounds. This makes our university stronger and ensures we hire the best talent. For each of the last six years, RCSI has been positioned in the Top 300 of universities worldwide in the Times Higher World University Rankings. We are proud that RCSI ranks first in the world for "Good Health and Well-being" in the Times Higher Education #SDG #SDG Impact Rankings 2025. This reflects our commitment to supporting people of all ages to live healthy lives and our work to promote the concepts of well-being and positive health. Our values of Respect, Collaboration, Scholarship and Innovation continue to unite and direct our purpose. Innovating for a Healthier Future is RCSI's new five-year strategic plan. Through it, RCSI will enhance human health by meeting the health workforce needs of society, creating the insights and inventions that drive health improvements, and working in partnership with patients and the public in support of better health and well-being for all. The strategy unites the RCSI community in supporting the UN Sustainable Development Goals - with a particular focus on Goal 3, which targets good health and well-being. More details about RCSI can be ; in particular. At RCSI, our core values of Respect, Collaboration, Scholarship, and Innovation are at the heart of everything we do. We are committed to creating an inclusive and supportive environment where every colleague is valued and empowered to thrive. Our dedication to these values ensures that we foster a culture of mutual respect, open collaboration, continuous learning, and innovative thinking. Join us at RCSI, where your contributions will be recognised, and you will be part of a dynamic team making a real impact on global health. Objective of this post: The Open Research Librarian manages, develops, and delivers services in support of Open Research, including the operation and development of the RCSI Repository, promotion and training on Open Access, advice and support for Open Access agreements, research impact and metrics, copyright and open publishing. 1. Open research Lead the promotion and delivery of support for researchers on open access publishing and support the dissemination of RCSI research outputs through open research practices. Collaborate with library colleagues to coordinate the development, promotion and delivery of the range of Library research support services Build strong working relationships with the RCSI research community, Office of Research and Innovation, Insights and Planning Office, and other internal stakeholders as appropriate. Represent the Library on relevant internal and external working groups and committees as required, taking an active role in national groups and initiatives on open research Develop and maintain strong peer networks across higher education and other sectors to inform service development and enhance collaboration. Keep abreast of trends, developments and policies relating to open research both nationally and internationally 2. Repository and infrastructure Manage the daily operation of the RCSI Repository, ensuring effective processes are in place and consistent standards are being followed. Manage the repository workloads amongst the supporting staff, ensuring timely approval of new additions, monitoring of new publications, and follow up with authors where needed. Take the lead in planning the ongoing development of the repository to ensure it continues to meet the needs of RCSI, working with the Library Digital Systems and Services Coordinator, IT, the service provider and further colleagues as needed Stay up to date with functional aspects of the Research Information Management System (RIMS - currently provided by Symplectic Elements) and in particular its effects on and integration with the repository Work with the repository provider (currently Figshare) and take part in the provider community Play an active role in Open Repositories Ireland and any other relevant cooperative communities on repositories and their standards Maintain operational and system documentation including the production of usage reports, relevant policies and procedures, and ensure the ongoing application of appropriate metadata standards Work with appropriate partners to ensure the ongoing effective integration of the repository and its metadata into national and international gateways 3. OA Agreements and copyright Provide expert guidance, consultation and support to researchers on scholarly communications issues including authors' rights and licencing, funder open access dissemination requirements, open access publishing options and open research principles and practices Promote the Library's open access publishing agreements, managing the approvals process and providing advice to authors Provide copyright advice to library users and update and maintain guidance on copyright for researchers, educators and students 4. Research Visibility and Impact Support and provide training to researchers on the use of bibliometric tools to evaluate impact, including helping to provide or verify individual metrics for promotions, grant applications, etc. Offer assistance and advice to researchers on maintaining a researcher profile on RIMS and other external services Promote and monitor the adoption and use of ORCiD, highlighting its benefits to researchers Work closely with key university stakeholders, provide expert advice and assistance on the appropriate and responsible use of citation-based metrics and other relevant research impact measures and tools Actively engage with the university's Insights & Planning Office, coordinating support and training for researchers and departments on research metrics, and helping ensure their accurate and responsible use. 5. Line Management and supervision Provide direction and supervision to paraprofessional staff supporting Research Support including but not limited to, proactive delegation of tasks, supervision and review of work processes and workflows; staff training; professional development planning, aligning team activities with operational and strategic goals. 6. Training Develop and implement appropriate outreach and training aimed at research staff and postgraduate students relating to all aspects of open access publishing, the evolving scholarly communications landscape and, in cooperation with the Research Data Coordinator, on open research practices and approaches Develop, maintain and update appropriate online guidance through LibGuides and other means, and promote and educate RCSI users on all aspects of Open Research and related areas. 7. Other Providing usage statistics and management information as required Evaluating programmes and services Making a positive contribution to all aspects of the library service Performing other duties as may be assigned Complying with statutory legislation and rules and requirements in furtherance of your own and general staff welfare and safety. Undergoing programmes of training and development relevant to the role and as may be required from time to time. Representing the best interests of RCSI at all times. Knowledge & Experience ESSENTIAL DESIRABLE QUALIFICATIONS Post-graduate qualification in library or information science or equivalent Evidence of commitment to CPD Membership of relevant professional association (s) Open Research training EXPERIENCE Experience of working in academic libraries or equivalent Working with digital content and metadata standards Providing services and support to researchers Experience of working in health sciences libraries Repository management and systems, ideally Figshare Working with bibliometrics and research profiles KNOWLEDGE Familiarity with best practice in academic libraries in general Open access publishing and the wider open research environment Institutional repositories and repository management including standards and copyright Familiarity with bibliometrics and citation tools Expert knowledge of health sciences information resources Emerging trends and current issues in academic libraries and higher education sector in Ireland Researcher profile tools, especially ORCiD SKILLS Excellent written and verbal communication skills Excellent presentation skills Good organisational, analytical, problem solving and time-management skills Very strong IT skills PERSONAL ATTRIBUTES Excellent customer service focus & commitment Highly collaborative team player Self-directed, enthusiastic and motivated Adaptable OTHER Able to work flexibly in response to service needs Committed to equality and diversity Willing to travel between sites if required We are all too aware that imposter syndrome and the confidence gap can sometimes stop fantastic candidates putting themselves forward, so please do submit an application - we'd love to hear from you. Application Process Please apply online through the RCSI careers portal on the closing date with your CV and cover letter. Click here to read our Recruitment and Selection Policy for Researcher. Informal Enquiries: Informal enquiries are invited in the first instance through Rebecca O'Brien, Human Resources Department (email: ). All applications for this post must be made through the career's webpage Rebecca can arrange for relevant queries on the academic aspects of the role to be addressed by the hiring manager. Please note we do not accept CVs directly. Garda vetting and occupational health review may be required for this role, depending on the nature of the duties and responsibilities. Further information will be provided during the recruitment process. Employee Benefits At RCSI, we help care for our people so they can focus on our mission to Educate, nurture and discover for the benefit of human health. RCSI truly goes above and beyond to support its employees, ensuring they have everything they need to thrive both personally and professionally. Here's a glimpse of the fantastic benefits available: Health and Wellbeing: Our Inspire Programme promotes the importance of taking care of both our general health and mental health. Inspire manages the Employee Assistance Programme (EAP) offered through SpectrumLife. Past events held by Inspire have included, workshops on mindfulness practices, yoga, nutritional advice, financial advice on mortgages, pensions & health insurance from leading experts, fitness challenges, baking competitions, weight loss programmes, annual flu vaccination campaign and many more. You can also enjoy access to an onsite gym for just €10 per month. Work -Life Balance: Maintaining a healthy work-life balance is crucial for fostering employee well-being, productivity, and overall satisfaction. At RCSI, we offer flexible working arrangements, study leave, and career breaks. In addition to 20 days of annual leave, employees receive an extra 6.5 days of university privilege days, which occur annually around the Christmas and Easter breaks. Family Benefits: RCSI offers enhanced family leave to our working parents with fully paid Maternity, Adoptive, Paternity and Surrogacy Leave. We also offer the first two weeks of Parents leave fully paid for, as well as the option to take Parental Leave until your child is 18 years old. We provide access to Platform 55, a new Parents Platform to support staff before, during, and after becoming a parent. We also offer flexible working, discounted Giraffe crche services of up to 20% and a Parents and Carers' Network. Financial Security: Benefit from automatic enrolment in a pension scheme with Willis Towers Watson with the employer contributions increasing with your length of service, Death in Service of up to 4 times your salary, long-term illness and disability income replacement, and free advice on health, motor, and home insurance. Discounted Services: Avail of discounted GP services, Taxsaver commuter tickets, the BiketoWork scheme, free eye tests at the National Optometry Centre, and discounted parking at St. Stephen's Green/RCSI car park. Recognition: At RCSI, we value and recognise the contributions of our staff through various awards and events, such as Long Service recognition, the Vice Chancellor Staff Awards, and through Research Day. Professional Growth: RCSI's Staff Learning and Development is committed to providing colleagues with opportunities and support to help them reach their full potential and thrive at work. Offerings include a comprehensive programme of staff training, management and leadership development, mentoring, coaching and funding support for further study. Staff Networks: Additionally, we support a range of staff networks, including the Women's Network, Postdoctoral Staff Network, Parents & Carers' Network, Project Manager's Network, LGBTI+ Network, Age Friendly Network etc. These networks help RCSI to foster a sense of community and inclusivity. Sports and Social Club: Engage in a variety of activities such as Yoga, Pilates and a variety of different Fitness classes. Enjoy social evenings, Book Clubs, Summer BBQs and one-off events like the Taste of Dublin, Bloom, Dublin Horse Show and Dublin Zoo. We also have a variety of discount tickets for shows and events through the year. Note: This job description may be subject to change to reflect the evolving requirements of the Department and RCSI. Similar vacancies that arise in the next 6 months may be filled from the pool of applicants that apply for this position. RCSI is proud to be an equal opportunity employer and welcome applications from all suitably qualified persons regardless of their gender, civil status, family status, sexual orientation, religion, age, disability or race. RCSI is committed to embedding equality, diversity and inclusion (EDI) across everything we do. This ensures we can all work and learn in an environment defined by dignity and respect. Eligibility to work in Ireland is a requirement of this role, Proof of eligibility documentation will be required at a later date. Under limited and specific circumstances (research/ specialist roles) RCSI may be in a position to seek a hosting agreement and/or work permits. Employees are required to undertake 6 months service in their current role before applying for other internal opportunities, unless agreed in advance by the SMT representative
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