28 Research Study jobs in Ireland

We are seeking an experienced operations professional to manage critical data acquisition infrastructure supporting advanced AI model development. This contract role requires exceptional operational acumen, demonstrated ability to scale complex workflows, and meticulous attention to quality standards across high-volume data collection initiatives.

Strategic Operations Management

• Oversee end-to-end execution of multiple concurrent data acquisition programs encompassing speech, visual, textual, and audio content streams

• Develop and implement scalable operational frameworks ensuring consistent achievement of volumetric targets while maintaining stringent quality thresholds

• Drive continuous process improvement through systematic identification and elimination of operational inefficiencies

Stakeholder & Contributor Management

• Design comprehensive contributor engagement strategies optimizing recruitment, onboarding, retention, and successful task completion

• Establish robust support infrastructure delivering timely resolution of technical and procedural inquiries

• Cultivate productive relationships with internal stakeholders through transparent communication and data-driven insights

Quality Assurance & Compliance

• Implement rigorous quality control methodologies maintaining data acceptance rates exceeding 95%

• Ensure strict adherence to data governance protocols, consent management, and regulatory requirements

• Develop predictive quality indicators enabling proactive intervention and remediation

Performance Analytics & Reporting

• Generate comprehensive operational intelligence providing actionable insights for strategic decision-making

• Establish KPI frameworks measuring throughput, quality, efficiency, and contributor satisfaction

• Deliver regular executive summaries highlighting achievements, challenges, and optimization opportunities

This position offers complete location flexibility within European time zones. Candidates must maintain reliable high-speed internet connectivity and professional home office environment conducive to managing distributed operations.

Qualified candidates should demonstrate clear alignment with outlined competencies and provide specific examples of operational excellence in similar environments. We value diverse perspectives and encourage applications from candidates with non-traditional backgrounds who possess relevant transferable skills.

Professional Experience

• Minimum 1-3 years operational management experience within data-intensive environments (crowdsourcing platforms, research operations, content moderation, or similar domains)

• Demonstrated success managing distributed contributor networks (100+ simultaneous participants)

• Proven ability to meet aggressive performance targets while maintaining exceptional quality standards

Technical & Analytical Competencies

• Proficiency in operational tools and platforms for workflow management, data tracking, and process automation

• Strong analytical capabilities with experience translating complex data into actionable operational strategies

• Familiarity with quality assurance methodologies and statistical sampling techniques

Communication & Leadership

• Exceptional written and verbal communication skills in English (additional languages highly valued)

• Experience delivering technical support through multiple channels (email, chat, ticketing systems)

• Ability to influence without authority and drive results through collaborative partnerships

Clinical research Assistant - Dublin 15

Job Description

The CRP is an Irish company, specialising in undertaking clinical research trials for a range of different organisations. We are looking for a Clinical Research Assistant to join our growing team. The position will suit somebody who is interested in the field of clinical research, enjoys patient interaction, and has great attention to detail and good IT skills (Word and Excel)

This position is primarily responsible for the accurate completion of visit procedures and collection of information for study patients according to protocols, and for protecting the health, safety, and welfare of research participants. A medical background is preferable but not essential; however the successful applicant will have a strong interest in working in a medical environment.

Duties

• The Research Assistant will support the day-to-day administration of the studies working closely with the research staff/ manager.
• Support the project and ensure trial delivery.
• Oversee the collection of qualitative and quantitative data
• Strong time management and problem-solving skills
• Ability to work without direct supervision, paying close attention to detail and bearing independent responsibility for data accuracy
• Proven ability to manage multiple projects with the ability to handle several responsibilities and work under tight time constraints
• Proven experience in dealing with all levels of staff in responding to a wide range of tasks/duties
• Ability to use tact, discretion, and sound judgment when dealing with confidential information
• Proficiency in MS Excel - including basic functions and formulas, Word, PowerPoint
• Familiarity with database management tools would be a plus
• Actively participate as a member of a research team.
• Attend and contribute to relevant meetings.
• Work with colleagues on joint projects, as required.
• Dealing with problems which may affect the achievement of research objectives and deadlines.
• Responding to internal and external queries about research and data entry.
• Initiating continuous improvement in your own areas of responsibility.
• Performing any other reasonable duties as directed by line management.

Job Type: Full-time

Pay: €30,000.00-€38,000.00 per year

Work Location: In person

About Teckro

We founded Teckro to simplify and modernize clinical trials. In fact, thousands of clinical trial investigators and research site staff rely on Teckro to make the most informed decisions for their patients.

That's where you come in. We're offering you a role with purpose. Your contribution at Teckro will lead to faster, safer and more efficient clinical trials. Quality of life will be improved. In the end, lives will be saved.

Could you be our newest Teckronaut?

What you'll Do:

• Responsible for the training, mentoring and development of CRS Level 1, including the preparation and development of training materials and tools
• Assisting with the updating of clinical operations process guides
• Responsible for quality checking previously developed projects as part of risk assessment
• Involved in the assessment of client documents prior to project development to determine project timelines
• As delegated, will assist in the planning and backlog of projects
• Analyse, understand, and process complex scientific/medical/pharmaceutical information
• Work with study teams and internal project teams to ensure timely delivery of high-quality solutions
• Execute the layout and structure of clinical information required to utilize our products efficiently and effectively
• Monitor, analyze, and action end user feedback and usage analysis metrics to evaluate and improve usability and accuracy of our products
• Successfully complete the 'In-House Clinical Trial Training Programme' delivered by a Senior CRS, covering all aspects of Clinical Trials, including but not limited to: trial design, trial procedures, ICH-GCP, clinical trial regulations, operational activities, safety reporting, monitoring etc. The CRS Level 2 will be deemed competent by both the Senior CRS and CRS Manager.
• Undertake other duties in-line with your role and business requirements as required

Multilingual CRS:

• Assist with translation tasks across various departments within the company
• To perform study demos of Teckro, to join Investigator's Meetings (IMs) and to provide training in local languages to study teams and/or relevant users

The Ideal candidate will have:

• Japanese speaker, with the ability to communicate fluently; including reading, writing, listening and speaking.
• Genuine interest in clinical research, medical advancement and drug and biotechnology development highly beneficial as there is room for advancement within the Clinical Trials area in Teckro.
• Superb editorial skills with a keen eye for text and graphic layouts
• Strong critical thinking and problem solving skills
• Strong multi-tasking and time management skills including the ability to effectively prioritise tasks, depending on timelines and demands
• Strong interpersonal, verbal and written communication skills
• Superb editorial skills with a keen eye for text and graphic layouts
• Proven ability to organize information in a logical and systematic way
• Ability to focus on fine details and the wider system at the same time
• Extreme attention to detail and accuracy even when balancing multiple projects
• Highly adaptable and flexible
• Ability to quickly and easily switch contexts, particularly between creative and analytical work
• Passion for creative solutions, innovation, and divergent thinking
• Demonstrated ability to work well as part of a team
• Where a candidate is carry out duties in a specific language, proven spoken and written fluency is essential

Qualifications Required:

• At least 18+ months relevant experience with proven competencies in the role.
• Degree in biological science, pharmacy, pharmacology, other health-related field or prior qualifications or experience in technical communications preferred
• Excellent computer skills

Location and Travel:

(Dublin)

• Hybrid role - Dublin City Centre, Ireland.
• Our Dublin City Centre offices are located less than 3 mins for Pearse St Dart Station and beside the Alex Hotel, making it accessible for all major transport.
• We also offer flexible start/ end times, allowing your schedule to suit your lifestyle
• Note: Regrettably we cannot offer work permit sponsorship for this role .To be considered, you must currently be based in Ireland and already hold the necessary legal permissions to work here.

Teckro Benefits:

• 25 days holidays
• Pension
• Healthcare
• Life Insurance
• Share Options
• 50% Maternity leave pay after capped length of service
• Paid Paternity leave scheme
• Bike to Work/ Tax Saver Scheme
• Gym/Wellness Allowance
• Sports and Social Club

We are always looking for amazing people to join our growing team. If you are curious, passionate and motivated, then we want to talk to you

By submitting your application, you agree that Teckro may collect your personal data for recruiting and related purposes. Teckro's Recruitment Privacy Statement explains what personal information Teckro may process, where Teckro may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Teckro's use of your personal information.

*Research Nurse - Clinical Provider & Global Healthcare - Carlow*

Location: Carlow, Ireland

Start date:
ASAP

Type:
Ad-hoc hours

Job Description

Partnered with a leading global
CQC-registered clinical provider
specializing in
home-based healthcare services
. Founded by clinical nurse specialists, they deliver
bespoke nursing solutions
across a wide range of therapy areas, including drug administration, patient education, and clinical trial support.

Our client is seeking qualified freelance nurses with proven clinical trial experience to support ad-hoc home-based clinical services.

Key Requirements:

• GCP Certificate (R3)
  – Must hold or be in process of obtaining the updated version
• Clinical Trial Experience
  – Strongly preferred for immediate consideration
• Must have
  relevant immunisations
  prior to submission
• Flexible availability during weekdays; schedules provided well in advance
• Able to balance multiple freelance commitments effectively

Essential Clinical Skills:

• Venipuncture
• Centrifuge
• ECG (performance only – no interpretation required)
• Cannulation
• Port-a-Cath (access & de-access)
• Injection administration

Candidate Profile:

• Registered nurse with
  minimum 3 years' qualification
• At least
  1 year acute care experience
• Own a car and willing to travel
• Currently working as a
  freelancer
  or with availability for ad-hoc support

If this role isn't suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated Planet Pharma offers a competitive referral scheme so you will be rewarded for your help

About Planet Pharma

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognized by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency.

We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

About Teckro

We founded Teckro to simplify and modernize clinical trials. In fact, thousands of clinical trial investigators and research site staff rely on Teckro to make the most informed decisions for their patients.

That's where you come in. We're offering you a role with purpose. Your contribution at Teckro will lead to faster, safer and more efficient clinical trials. Quality of life will be improved. In the end, lives will be saved.

Could you be our newest Teckronaut?

What you'll Do:

• Responsible for the training, mentoring and development of CRS Level 1, including the preparation and development of training materials and tools
• Assisting with the updating of clinical operations process guides
• Responsible for quality checking previously developed projects as part of risk assessment
• Involved in the assessment of client documents prior to project development to determine project timelines
• As delegated, will assist in the planning and backlog of projects
• Analyse, understand, and process complex scientific/medical/pharmaceutical information
• Work with study teams and internal project teams to ensure timely delivery of high-quality solutions
• Execute the layout and structure of clinical information required to utilize our products efficiently and effectively
• Monitor, analyze, and action end user feedback and usage analysis metrics to evaluate and improve usability and accuracy of our products
• Successfully complete the 'In-House Clinical Trial Training Programme' delivered by a Senior CRS, covering all aspects of Clinical Trials, including but not limited to: trial design, trial procedures, ICH-GCP, clinical trial regulations, operational activities, safety reporting, monitoring etc. The CRS Level 2 will be deemed competent by both the Senior CRS and CRS Manager.
• Undertake other duties in-line with your role and business requirements as required

Multilingual CRS:

• Assist with translation tasks across various departments within the company
• To perform study demos of Teckro, to join Investigator's Meetings (IMs) and to provide training in local languages to study teams and/or relevant users

The Ideal candidate will have:

• Chinese speaker, with the ability to communicate fluently; including reading, writing, listening and speaking.

• Genuine interest in clinical research, medical advancement and drug and biotechnology development highly beneficial as there is room for advancement within the Clinical Trials area in Teckro.

• Superb editorial skills with a keen eye for text and graphic layouts

• Strong critical thinking and problem solving skills

• Strong multi-tasking and time management skills including the ability to effectively prioritise tasks, depending on timelines and demands
• Strong interpersonal, verbal and written communication skills
• Superb editorial skills with a keen eye for text and graphic layouts
• Proven ability to organize information in a logical and systematic way
• Ability to focus on fine details and the wider system at the same time
• Extreme attention to detail and accuracy even when balancing multiple projects
• Highly adaptable and flexible

• Ability to quickly and easily switch contexts, particularly between creative and analytical work

• Passion for creative solutions, innovation, and divergent thinking

• Demonstrated ability to work well as part of a team

• Where a candidate is carry out duties in a specific language, proven spoken and written fluency is essential

Qualifications Required:

• At least 18+ months relevant experience with proven competencies in the role.
• Degree in biological science, pharmacy, pharmacology, other health-related field or prior qualifications or experience in technical communications preferred
• Excellent computer skills

Location and Travel:

(Dublin)

• Hybrid role - Dublin City Centre, Ireland.
• Our Dublin City Centre offices are located less than 3 mins for Pearse St Dart Station and beside the Alex Hotel, making it accessible for all major transport.
• We also offer flexible start/ end times, allowing your schedule to suit your lifestyle
• Note: Regrettably we cannot offer work permit sponsorship for this role .To be considered, you must currently be based in Ireland and already hold the necessary legal permissions to work here.

Teckro Benefits:

• 25 days holidays
• Pension
• Healthcare
• Life Insurance
• Share Options
• 50% Maternity leave pay after capped length of service
• Paid Paternity leave scheme
• Bike to Work/ Tax Saver Scheme
• Gym/Wellness Allowance
• Sports and Social Club

We are always looking for amazing people to join our growing team. If you are curious, passionate and motivated, then we want to talk to you

By submitting your application, you agree that Teckro may collect your personal data for recruiting and related purposes. Teckro's Recruitment Privacy Statement explains what personal information Teckro may process, where Teckro may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Teckro's use of your personal information.

We are looking for a new research nurse to cover maternal leave to join our operation in Tallaght hospital. Experience of clinical research is preferable, but not essential.

The initial contract will be fixed term for around 6-9 months, but there is a good possibility that the role will become permanent after this, but we cannot guarantee this at this stage.

MAIN PURPOSE:

The research nurse will play a pivotal role in the coordination of clinical trials. Under the supervision of the research manager the post holder will be involved in executing all activities relating to the clinical studies, ensuring compliance with regulatory requirements.

MAIN DUTIES AND RESPONSIBILITIES:

Research responsibilities will include

· Working within CRP standard operating procedures and research protocols/plans ensuring the overall smooth running of clinical trials/Investigations in accordance with Good Clinical Practice (GCP) and applicable regulatory and ethical requirements.

· Study Coordination and management of multiple research projects

· Screening of patients to identify potential study candidates, evaluation and enrolment of suitable participants in clinical research trials/investigations under the direction and supervision of the Principal Investigator (PI).

· Management and accountability for Investigational Medicinal Product/Device (IMP/IMD)

· Playing a proactive role in driving on-going clinical research projects through participant recruitment, participant follow-ups, safety reporting, early identification of potential problems and regular feedback with Principal Investigator and research team.

· Ensuring the maintenance and upkeep of clinical research documentation, including site files, case record forms, monitoring arrangements, data correction, data collection and data entry as per GCP/protocol and data protection requirements.

· Ensuring prompt management of all study related correspondence.

· Ensuring research data is accurate and verifiable and is collected, stored and handled on site in compliance with the protocol and data protection requirements

· Preparation for and participation in monitoring visits and Internal/Sponsor/Regulatory audit/inspection as required

· Development and maintenance of strong relationships with research partners, key stakeholders and team members by acting as the first point of contact on a variety of research projects and liaising with project collaborators, stakeholders, and staff.

· Playing a pivotal role in educating relevant research and clinical staff on current and upcoming clinical trials/investigations

Clinical Practice responsibilities will include:

· Provide nursing knowledge, expertise and care to patients participating in a clinical trial. Ensure that patients are fully informed of all details pertaining to the clinical trial/research project prior to their recruitment as per GCP.

· Ensure patients understand their disease and the proposed research and standard treatment options.

· Attend out-patient clinics for the purpose of optimising patient recruitment to clinical research studies.

· Maintain competence in the area of relevant national and European standards including data privacy and ethical standards and regulations

· Ensure competence/training in all designated research activities prior to carrying out such activities on research participants

· Performs study procedures (e.g., Administration of IP. Oral, SC, IM, monitoring of infusions, Phlebotomy, obtain and process biological specimen samples, obtain ECG recordings, vital signs, Spirometry and safety assessments) as required by study protocol under the supervision of the Principal Investigator (PI)

· Ensure continuity of patient care by liaising with outside health care professionals, and those who are involved in clinical work where applicable.

· Use agreed processes to deal with referrals and enquiries from other hospitals

· Carry out other duties as appropriate to the post as may be assigned from time to time by line manager/CRP management team

Professional development

· Maintain professional registration

· Take responsibility for own professional development and skills updating including maintaining a record of training activities and experience gained.

· Work with PI and CRP management team to ensure the safe delivery of care to patient participating in the clinical study

· Work closely with CRP's Management to ensure that appropriate quality documentation and performance measures are in place for improved processes.

The post holder requires

· Degree in Nursing and a minimum of 3 years' nursing experience

· Current registration with the Nursing and Midwifery Board of Ireland (NMBI)

· Proven clinical skills such as basic life support training and ability to provide safe and high-quality nursing care to a wide variety of research participants across different disease spectrums.

· Excellent oral and written communication skills.

· Good organizational, analytical/critical thinking and problem-solving skills with an ability to prioritize tasks/workload and meet deadlines

· Evidence of accuracy and attention to detail

· Knowledge of Microsoft office applications and willingness to develop computer skills further

· Knowledge of relevant data protection requirements

· Understanding of Good Clinical Practice

· Ability to work autonomously or as part of a team and to demonstrate initiative.

It would be desirable that post holder would have:

· Have experience of working on clinical trials or within a research setting

· Be competent in phlebotomy procedures

· Biological sample handling and processing experience with IATA certification

Job Types: Full-time, Fixed term

Pay: €40,000.00-€56,000.00 per year

Education:

• Bachelor's (required)

Work Location: In person

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.

Organisation Overview
Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our 'Live Your BEST Life'

wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself

Primary Responsibilities
Through the application of scientific training and clinical training and expertise, the Development clinical research scientist 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 serves as a scientific resource for study teams, departments, and others as needed. 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.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.

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 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).

Business/ customer support (ore and post launch support)

• Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, brand team, clinical plans manager/project management associates and other cross-functional management during the development of the local business plan.
• Understand and anticipate the scientific information needs of all Development customers (payers, patients, health care providers).
• Actively address Development customer (payer, patient, and health care providers) questions in a timely fashion by leading data analyses and new clinical or global patient outcomes research efforts.
• Establish effective collaborations with marketing personnel in the various geographic regions to further corporate demand realization.
• Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts.
• Contribute as a scientific and medical expert to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value.
• Support business-to-business and business-to-government activities as medical expert.
• Contribute actively on an ongoing basis to the strategic planning for the brand.
• By offering scientific and creative input, contribute to the development, review, and approval of promotional materials and tactics as needed.
• Become familiar with market archetypes and potential influence on the medical interventions for the product.
• Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become a patient advocate, as well as a medical expert.
• Participate in PhRMA or other local or national trade associations as appropriate.

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, Six Sigma 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

Minimum Qualification Requirements

• An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of following
• 3-5 years of clinical experience or 3-5 years of pharmaceutical experience (2 of which is in clinical development)

OR

• Have a BS or Masters degree in health/medical/scientific or related field and 7-10 years of pharmaceutical experience that is directly related to at least one of the following
• Clinical trial experience Experience in areas relevant to drug discovery Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs)
• If experience is either in 2 and or 3 only (for example, no clinical trial experience), the following must be provided as supporting evidence of candidates ability/capability to perform in a CRS role
• Clear evidence and documentation of candidate's direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content= medical, scientific or clinical information)
• Candidate's selection for CRS role must be endorsed by the BU Med affairs/development VP or equivalent area Senior leadership
• Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
• Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills
• Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
• Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
• Fluent in English, verbal and written communication

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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

About Teckro

We founded Teckro to simplify and modernize clinical trials. In fact, thousands of clinical trial investigators and research site staff rely on Teckro to make the most informed decisions for their patients.

That's where you come in. We're offering you a role with purpose. Your contribution at Teckro will lead to faster, safer and more efficient clinical trials. Quality of life will be improved. In the end, lives will be saved.

Could you be our newest Teckronaut?

What you'll Do:

• Responsible for the training, mentoring and development of CRS Level 1, including the preparation and development of training materials and tools
• Assisting with the updating of clinical operations process guides
• Responsible for quality checking previously developed projects as part of risk assessment
• Involved in the assessment of client documents prior to project development to determine project timelines
• As delegated, will assist in the planning and backlog of projects
• Analyse, understand, and process complex scientific/medical/pharmaceutical information
• Work with study teams and internal project teams to ensure timely delivery of high-quality solutions
• Execute the layout and structure of clinical information required to utilize our products efficiently and effectively
• Monitor, analyze, and action end user feedback and usage analysis metrics to evaluate and improve usability and accuracy of our products
• Successfully complete the 'In-House Clinical Trial Training Programme' delivered by a Senior CRS, covering all aspects of Clinical Trials, including but not limited to: trial design, trial procedures, ICH-GCP, clinical trial regulations, operational activities, safety reporting, monitoring etc. The CRS Level 2 will be deemed competent by both the Senior CRS and CRS Manager.
• Undertake other duties in-line with your role and business requirements as required

Multilingual CRS:

• Assist with translation tasks across various departments within the company
• To perform study demos of Teckro, to join Investigator's Meetings (IMs) and to provide training in local languages to study teams and/or relevant users

The Ideal candidate will have:

• Genuine interest in clinical research, medical advancement and drug and biotechnology development highly beneficial as there is room for advancement within the Clinical Trials area in Teckro.

• Superb editorial skills with a keen eye for text and graphic layouts

• Strong critical thinking and problem solving skills

• Strong multi-tasking and time management skills including the ability to effectively prioritise tasks, depending on timelines and demands
• Strong interpersonal, verbal and written communication skills
• Superb editorial skills with a keen eye for text and graphic layouts
• Proven ability to organize information in a logical and systematic way
• Ability to focus on fine details and the wider system at the same time
• Extreme attention to detail and accuracy even when balancing multiple projects
• Highly adaptable and flexible

• Ability to quickly and easily switch contexts, particularly between creative and analytical work

• Passion for creative solutions, innovation, and divergent thinking

• Demonstrated ability to work well as part of a team

• Where a candidate is carry out duties in a specific language, proven spoken and written fluency is essential

Qualifications Required:

• At least 18+ months relevant experience with proven competencies in the role.
• Degree in biological science, pharmacy, pharmacology, other health-related field or prior qualifications or experience in technical communications preferred
• Excellent computer skills

Location and Travel:

(Dublin)

• Hybrid role - Dublin City Centre, Ireland.
• Our Dublin City Centre offices are located less than 3 mins for Pearse St Dart Station and beside the Alex Hotel, making it accessible for all major transport.
• We also offer flexible start/ end times, allowing your schedule to suit your lifestyle
• Note: Regrettably we cannot offer work permit sponsorship for this role .To be considered, you must currently be based in Ireland and already hold the necessary legal permissions to work here.

Teckro Benefits:

• 25 days holidays
• Pension
• Healthcare
• Life Insurance
• Share Options
• 50% Maternity leave pay after capped length of service
• Paid Paternity leave scheme
• Bike to Work/ Tax Saver Scheme
• Gym/Wellness Allowance
• Sports and Social Club

We are always looking for amazing people to join our growing team. If you are curious, passionate and motivated, then we want to talk to you

By submitting your application, you agree that Teckro may collect your personal data for recruiting and related purposes. Teckro's Recruitment Privacy Statement explains what personal information Teckro may process, where Teckro may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Teckro's use of your personal information.

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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.

*In-house Monitoring: *
Additional On-site Monitoring Responsibilities:

• 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

Location: EMEA : Ireland : Dublin | EMEA : Ireland : Home Office:Grange Castle (Dublin)
Learn more about Grifols