6 Bon Secours Health System jobs in Ireland
Associate Director Clinical Operations
Dublin, Leinster
Grifols Shared Services North America, Inc
Posted 7 days ago
Job Viewed
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:
Oversees the clinical feasibility assessment and strategic planning of clinical trial programs or studies. Executes on these global programs or studies in one or more assigned therapeutic area(s) from decision to start a clinical development up to the market authorization. Manages budgets, timelines and quality of deliverables for assigned program(s) and study(ies) in accordance with International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, applicable regulatory requirements, company standard operating procedures (SOPs), and study protocols.
KEY RESPONSIBILITIES:
- Oversees integrity of clinical data to ensure data meets GCP standards.
- Maintains good knowledge of the literature for the indication being studied and reviews and summarizes all published literature for the therapeutic area of interest.
- Participates in cross functional project teams and presents program information to internal and external audiences.
Investigator Sponsored Research Proposals:
- Provides clinical review/input to Investigator Sponsored Research proposals.
Clinical Development Strategy/Input:
- Assesses best strategic path forward for a clinical program and drives clinical strategy recommendations including timelines and cost to key stakeholders.
- Orchestrates expert meetings to elucidate the best clinical path forward for a clinical program.
- Identifies risks, mitigations, opportunities and contingency plans for assigned program(s) and study(ies).
- Escalates significant issues on program(s) and study(ies) to senior management in a timely manner.
Project Management Office /pCTSR:
- Drafts clinical components from decision to start a clinical development and up to the market authorization (DP1-DP5) gates, liaise cross-functionally to provide clinical input on all development stages and Target Product Profile, as necessary.
- Provides clinical status updates to the Project Management Office (PMO) and to the Upper Management.
Team Management/Trainings:
- Manages direct reports through performance evaluations and addressing professional development.
- Ensures compliance of each Clinical Development trial team with the trial-specific training requirements
- Participates and contributes to internal and external training for clinical program (e.g. Kick-off meeting, Investigator's meeting)
Vendor Management:
- Manages clinical timelines, budgets, and resources against the approved clinical development plan (CDP) in collaboration with contract manager.
- Participates in development of vendor specifications to ensure accurate interpretation of the protocol requirements (e.g. processes and data collection) and contributes to the vendor selection.
- Supports the Program Manager in overseeing third party vendors performance (e.g., contract research organizations (CROs), central labs) including on time study completion, budget adherence, and quality deliverables. In particular it may include the review of monitoring reports, approval of clinical plans, regular review of protocol deviations and activities related to the oversight of the trial master file (TMF) status, completed together with other clinical operations team members.
- Contributes to the evaluation of the vendor performance to ensure early mitigation/resolution of potential issues and develops/implements corrective action plans as appropriate, along with the Program Manager
- Performs Sponsor Site Visits at selected sites to oversee the site and the monitoring performances, to increase the communication with the site and awareness of protocol burdens. Documentation of the Sponsor Visits and follow-up of appropriate corrective and preventive actions.
Clinical Trial Design/Performance:
- Provides clinical review/input to clinical documents (e.g., protocols, investigator brochures, periodic safety reports and clinical study reports) and ensures the accuracy and integrity of clinical data prior to submission to regulatory authorities (e.g. Investigational New Drug (IND) application, Clinical Trial Application (CTA), Biologics License Application (BLA), Marketing Authorisation Application (MAA))
- Drafts or provides review/input for publications from clinical study data and white paper literature reviews on new products or safety questions.
- Participates in regulatory authority meetings.
- Partners with Biometry to develop the case report form, data management plan and statistical management plan.
- Reviews protocol deviations and data listings to ensure integrity of data and identify trends on ongoing basis.
- Provides oversight and collaboration with Biometry to ensure timely data transfers for data cleaning, review and analysis.
- Offers guidance to resolve escalated study conduct issues and provides clinical responses to questions from study center personnel, regulatory authorities and institutional review boards/ethics committees.
Audits/Inspections/Quality Assurance (QA):
- Oversees responses to vendor/site audits, as necessary.
- Oversees responses to internal audits.
- Contributes to processes improvement.
- Contributes to preparation of site inspections, attends site inspections, and supports responses to site inspections, as necessary
- Manages preparation of internal inspections, attends internal inspections, and manages responses to internal inspections.
- Supervises quality of the clinical trial and ensures implementation of Corrective and Preventive Actions to quality deviations and misconducts.
PERSON SPECIFICATION:
- 10+ years of experience in clinical research, including 2 to 5 years in a study management/leadership role. Advanced verbal, written and interpersonal skills that enable cross-functional issue resolution.
- Advanced strategic thinking abilities for proactive planning and decisive decision making.
- Advanced ability to set and meet deadlines, multitask, and prioritize based on program and/or study needs.
- Advanced ability to facilitate and/or present at departmental, study, project and investigator meetings.
- Strong leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel. Bachelor's degree in relevant discipline
- Typically requires a minimum of 10 years of clinical research experience with at least 6 years clinical trials management / leadership role, including clinical document production, trial execution and involvement in clinical trial feasibility and strategy.
- Master's degree or higher-level degree in relevant discipline. (2-years' experience equivalence for a MD and 4-years' experience for a master's degree).
- Advanced leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel.
**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
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
**Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3 ( more about Grifols
**Req ID:**
**Type:** Regular Full-Time
**Job Category:** Clinical Trials
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:
Oversees the clinical feasibility assessment and strategic planning of clinical trial programs or studies. Executes on these global programs or studies in one or more assigned therapeutic area(s) from decision to start a clinical development up to the market authorization. Manages budgets, timelines and quality of deliverables for assigned program(s) and study(ies) in accordance with International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, applicable regulatory requirements, company standard operating procedures (SOPs), and study protocols.
KEY RESPONSIBILITIES:
- Oversees integrity of clinical data to ensure data meets GCP standards.
- Maintains good knowledge of the literature for the indication being studied and reviews and summarizes all published literature for the therapeutic area of interest.
- Participates in cross functional project teams and presents program information to internal and external audiences.
Investigator Sponsored Research Proposals:
- Provides clinical review/input to Investigator Sponsored Research proposals.
Clinical Development Strategy/Input:
- Assesses best strategic path forward for a clinical program and drives clinical strategy recommendations including timelines and cost to key stakeholders.
- Orchestrates expert meetings to elucidate the best clinical path forward for a clinical program.
- Identifies risks, mitigations, opportunities and contingency plans for assigned program(s) and study(ies).
- Escalates significant issues on program(s) and study(ies) to senior management in a timely manner.
Project Management Office /pCTSR:
- Drafts clinical components from decision to start a clinical development and up to the market authorization (DP1-DP5) gates, liaise cross-functionally to provide clinical input on all development stages and Target Product Profile, as necessary.
- Provides clinical status updates to the Project Management Office (PMO) and to the Upper Management.
Team Management/Trainings:
- Manages direct reports through performance evaluations and addressing professional development.
- Ensures compliance of each Clinical Development trial team with the trial-specific training requirements
- Participates and contributes to internal and external training for clinical program (e.g. Kick-off meeting, Investigator's meeting)
Vendor Management:
- Manages clinical timelines, budgets, and resources against the approved clinical development plan (CDP) in collaboration with contract manager.
- Participates in development of vendor specifications to ensure accurate interpretation of the protocol requirements (e.g. processes and data collection) and contributes to the vendor selection.
- Supports the Program Manager in overseeing third party vendors performance (e.g., contract research organizations (CROs), central labs) including on time study completion, budget adherence, and quality deliverables. In particular it may include the review of monitoring reports, approval of clinical plans, regular review of protocol deviations and activities related to the oversight of the trial master file (TMF) status, completed together with other clinical operations team members.
- Contributes to the evaluation of the vendor performance to ensure early mitigation/resolution of potential issues and develops/implements corrective action plans as appropriate, along with the Program Manager
- Performs Sponsor Site Visits at selected sites to oversee the site and the monitoring performances, to increase the communication with the site and awareness of protocol burdens. Documentation of the Sponsor Visits and follow-up of appropriate corrective and preventive actions.
Clinical Trial Design/Performance:
- Provides clinical review/input to clinical documents (e.g., protocols, investigator brochures, periodic safety reports and clinical study reports) and ensures the accuracy and integrity of clinical data prior to submission to regulatory authorities (e.g. Investigational New Drug (IND) application, Clinical Trial Application (CTA), Biologics License Application (BLA), Marketing Authorisation Application (MAA))
- Drafts or provides review/input for publications from clinical study data and white paper literature reviews on new products or safety questions.
- Participates in regulatory authority meetings.
- Partners with Biometry to develop the case report form, data management plan and statistical management plan.
- Reviews protocol deviations and data listings to ensure integrity of data and identify trends on ongoing basis.
- Provides oversight and collaboration with Biometry to ensure timely data transfers for data cleaning, review and analysis.
- Offers guidance to resolve escalated study conduct issues and provides clinical responses to questions from study center personnel, regulatory authorities and institutional review boards/ethics committees.
Audits/Inspections/Quality Assurance (QA):
- Oversees responses to vendor/site audits, as necessary.
- Oversees responses to internal audits.
- Contributes to processes improvement.
- Contributes to preparation of site inspections, attends site inspections, and supports responses to site inspections, as necessary
- Manages preparation of internal inspections, attends internal inspections, and manages responses to internal inspections.
- Supervises quality of the clinical trial and ensures implementation of Corrective and Preventive Actions to quality deviations and misconducts.
PERSON SPECIFICATION:
- 10+ years of experience in clinical research, including 2 to 5 years in a study management/leadership role. Advanced verbal, written and interpersonal skills that enable cross-functional issue resolution.
- Advanced strategic thinking abilities for proactive planning and decisive decision making.
- Advanced ability to set and meet deadlines, multitask, and prioritize based on program and/or study needs.
- Advanced ability to facilitate and/or present at departmental, study, project and investigator meetings.
- Strong leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel. Bachelor's degree in relevant discipline
- Typically requires a minimum of 10 years of clinical research experience with at least 6 years clinical trials management / leadership role, including clinical document production, trial execution and involvement in clinical trial feasibility and strategy.
- Master's degree or higher-level degree in relevant discipline. (2-years' experience equivalence for a MD and 4-years' experience for a master's degree).
- Advanced leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel.
**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
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
**Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3 ( more about Grifols
**Req ID:**
**Type:** Regular Full-Time
**Job Category:** Clinical Trials
This advertiser has chosen not to accept applicants from your region.
0
Clinical Nurse Manager III (Clinical Operations)
Galway, Connacht
recruitNet
Posted 576 days ago
Job Viewed
Job Description
RecruitNet International Ltd is specializing in relocating qualified professionals throughout Ireland and overseas, we guide you through the professional registration, job placement, visa and employment permit processing.We are hiring Clinical Nurse Manager III (Clinical Operations) into a Private Hospital in Galway, Ireland. 30 hours per week Permanent Contract We will provide exceptional patient care in an environment where quality, respect, caring and compassion are at the centre of all we do. Key Responsibilities Responsible for selecting, training, and developing a team comprised of CTAs, CRAs, or a mixture of rolesIn charge of staff time management, time off, and salary reviewsPromotes quality and performance standards for clinical trial administration and works to ensure they are documented and understood by the entire teamWorks to ensure that billing rates are maintained and appropriate levelsActs as a liaison with other managers in order to assess staff allocation and identify team members available for potential studiesMaintains staff allocation databasePerform other duties as requiredRequirementsCandidate should have a minimum of 5 years of experience. R.G.N RegistrationCandidate should have management experience. Excellent interpersonal, leadership, accountability and communication skillsAppropriate clinical and managerial skills with evidence of continuing professional developmentBenefitsTop pay and great working conditionsImmediate Start, Full time PermanentGreat professional development opportunityContinued education and training.
This advertiser has chosen not to accept applicants from your region.
1
Healthcare Assistant - Mental Health Services
Dunboyne, Leinster
Nua Healthcare
Posted 1 day ago
Job Viewed
Job Description
Job Summary Nua Healthcare Services (Nua) is one of Ireland's leading Private Healthcare Providers, specialising in Mental health, Residential and Supported Living Services, to both Children and Adults with a range of complex support needs. We are seeking applications from energetic and enthusiastic individuals wanting to progress in their career as a healthcare assistant within the Mental Health Sector, where our team bring a wealth of experience in supporting individuals with a range of Mental illnesses. The successful candidate will be afforded all necessary training and development in line with the role. Job Objectives We are seeking Healthcare Assistants to join our dynamic team at Nua Healthcare. Live our Mission, Vision and Values. To co-operate with your employer and to comply with your responsibilities under The Mental Health Act 2001 and Mental Health Amendment Act 2018, the Safety Health and Welfare at Work Act 2005 and all associated standards, regulations, and codes of practice in so far as is reasonable and practicable. To be familiar with and to adhere to all company policies and procedures. Respect patients and their families showing dignity, courtesy, and professionalism at all times. Maintain the confidentiality of all information made available to him / her during the course of his / her work. Support patients with mental and emotional issues under the supervision of Psychiatrists and other mental health professionals. Support Patients in performing their daily activities. When directed to do so support patients with daily activities such as eating, self-care and care of their immediate environment. When directed to do so observe, monitor and record patients' conditions by taking temperatures, pulse, respirations and weight Support Patients with therapy and rehabilitation programmes designed to enable patients to work towards their goals for independent living as prescribed by healthcare professionals. To support in the overall safe running of the Unit. To complete documentation, including patient records and timesheets. This list of key responsibilities is not exhaustive. Skills Requirement Qualification: Fetac Level 5 in Health Care or equivalent preferable but not essential. Knowledge: Knowledge of the Mental Health Act 2001 Knowledge of the Mental Health Commission Experience: Minimum of 1 year experience working in a similar healthcare setting desirable however not essential Skills: Full Clean Driver's licence or working towards desirable however not essential Strong Communication/Listening skills Work well as part of a team Strong Observational Skills Benefits Company Pension Life Assurance/Death-in-Service Paid Maternity/Paternity Leave Education Assistance Employee Assistance Programme (EAP) Working hours over a 7 day roster involving shift work Continuous Professional Development Fantastic development & career opportunities Bike to work Scheme Refer a friend bonus Discounts with Retailers - Nationwide #Nua1 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Apply button below to Login/Register.
This advertiser has chosen not to accept applicants from your region.
2
Healthcare assistant - mental health services
Meath, Leinster
Nua Healthcare
Posted today
Job Viewed
Job Description
Job Summary Nua Healthcare Services (Nua) is one of Ireland's leading Private Healthcare Providers, specialising in Mental health, Residential and Supported Living Services, to both Children and Adults with a range of complex support needs.
We are seeking applications from energetic and enthusiastic individuals wanting to progress in their career as a healthcare assistant within the Mental Health Sector, where our team bring a wealth of experience in supporting individuals with a range of Mental illnesses.
The successful candidate will be afforded all necessary training and development in line with the role.
Job Objectives We are seeking Healthcare Assistants to join our dynamic team at Nua Healthcare.
Live our Mission, Vision and Values.
To co-operate with your employer and to comply with your responsibilities under The Mental Health Act 2001 and Mental Health Amendment Act 2018, the Safety Health and Welfare at Work Act 2005 and all associated standards, regulations, and codes of practice in so far as is reasonable and practicable.
To be familiar with and to adhere to all company policies and procedures.
Respect patients and their families showing dignity, courtesy, and professionalism at all times.
Maintain the confidentiality of all information made available to him / her during the course of his / her work.
Support patients with mental and emotional issues under the supervision of Psychiatrists and other mental health professionals.
Support Patients in performing their daily activities.
When directed to do so support patients with daily activities such as eating, self-care and care of their immediate environment.
When directed to do so observe, monitor and record patients' conditions by taking temperatures, pulse, respirations and weight Support Patients with therapy and rehabilitation programmes designed to enable patients to work towards their goals for independent living as prescribed by healthcare professionals.
To support in the overall safe running of the Unit.
To complete documentation, including patient records and timesheets.
This list of key responsibilities is not exhaustive.
Skills Requirement Qualification: Fetac Level 5 in Health Care or equivalent preferable but not essential.
Knowledge: Knowledge of the Mental Health Act 2001 Knowledge of the Mental Health Commission Experience: Minimum of 1 year experience working in a similar healthcare setting desirable however not essential Skills: Full Clean Driver's licence or working towards desirable however not essential Strong Communication/Listening skills Work well as part of a team Strong Observational Skills Benefits Company Pension Life Assurance/Death-in-Service Paid Maternity/Paternity Leave Education Assistance Employee Assistance Programme (EAP) Working hours over a 7 day roster involving shift work Continuous Professional Development Fantastic development & career opportunities Bike to work Scheme Refer a friend bonus Discounts with Retailers - Nationwide #Nua1 To be considered for this role you will be redirected to and must complete the application process on our careers page.
To start the process click the Apply button below to Login/Register.
We are seeking applications from energetic and enthusiastic individuals wanting to progress in their career as a healthcare assistant within the Mental Health Sector, where our team bring a wealth of experience in supporting individuals with a range of Mental illnesses.
The successful candidate will be afforded all necessary training and development in line with the role.
Job Objectives We are seeking Healthcare Assistants to join our dynamic team at Nua Healthcare.
Live our Mission, Vision and Values.
To co-operate with your employer and to comply with your responsibilities under The Mental Health Act 2001 and Mental Health Amendment Act 2018, the Safety Health and Welfare at Work Act 2005 and all associated standards, regulations, and codes of practice in so far as is reasonable and practicable.
To be familiar with and to adhere to all company policies and procedures.
Respect patients and their families showing dignity, courtesy, and professionalism at all times.
Maintain the confidentiality of all information made available to him / her during the course of his / her work.
Support patients with mental and emotional issues under the supervision of Psychiatrists and other mental health professionals.
Support Patients in performing their daily activities.
When directed to do so support patients with daily activities such as eating, self-care and care of their immediate environment.
When directed to do so observe, monitor and record patients' conditions by taking temperatures, pulse, respirations and weight Support Patients with therapy and rehabilitation programmes designed to enable patients to work towards their goals for independent living as prescribed by healthcare professionals.
To support in the overall safe running of the Unit.
To complete documentation, including patient records and timesheets.
This list of key responsibilities is not exhaustive.
Skills Requirement Qualification: Fetac Level 5 in Health Care or equivalent preferable but not essential.
Knowledge: Knowledge of the Mental Health Act 2001 Knowledge of the Mental Health Commission Experience: Minimum of 1 year experience working in a similar healthcare setting desirable however not essential Skills: Full Clean Driver's licence or working towards desirable however not essential Strong Communication/Listening skills Work well as part of a team Strong Observational Skills Benefits Company Pension Life Assurance/Death-in-Service Paid Maternity/Paternity Leave Education Assistance Employee Assistance Programme (EAP) Working hours over a 7 day roster involving shift work Continuous Professional Development Fantastic development & career opportunities Bike to work Scheme Refer a friend bonus Discounts with Retailers - Nationwide #Nua1 To be considered for this role you will be redirected to and must complete the application process on our careers page.
To start the process click the Apply button below to Login/Register.
This advertiser has chosen not to accept applicants from your region.
3
Director, Program Operations Leader - Early Phase Clinical Trials
Dublin, Leinster
Regeneron Ireland
Posted 9 days ago
Job Viewed
Job Description
For US Locations, this position is on-site 4 days per week and 1 day from home. For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position. The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The Dir POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The Dir POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment, development, coaching, mentoring, and performance management. In a typical day, you will: Be responsible for the overall success of the clinical study team(s) within a program(s) Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development Oversee clinical study timelines within a clinical program(s) Provide input and operational insight into Clinical Study Concepts (CSC) Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s). Drives decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation Be responsible for direct supervision of CTM staff. Line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight. To be considered, you must possess: A Bachelor's degree and minimum of 12 years relevant in-house sponsor-side industry experience, 8 years within clinical operations. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $0.00 - $0.00
This advertiser has chosen not to accept applicants from your region.
4
Director, program operations leader - early phase clinical trials
Dublin, Leinster
Regeneron Ireland
Posted today
Job Viewed
Job Description
For US Locations, this position is on-site 4 days per week and 1 day from home.
For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home.
A fully remote role is not possible for this position.
The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM).
This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s).
The Dir POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives.
The Dir POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment, development, coaching, mentoring, and performance management.
In a typical day, you will: Be responsible for the overall success of the clinical study team(s) within a program(s) Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development Oversee clinical study timelines within a clinical program(s) Provide input and operational insight into Clinical Study Concepts (CSC) Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies.
Ensure consistency within the program and development of best practices within CTM Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s).
Drives decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation Be responsible for direct supervision of CTM staff.
Line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.
To be considered, you must possess: A Bachelor's degree and minimum of 12 years relevant in-house sponsor-side industry experience, 8 years within clinical operations.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way.
We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.
S., the salary ranges provided are shown in accordance with U.
S.
law and apply to U.
positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency.
If you are outside the U.
S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process.
Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.
The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually) $0.00 - $0.00
For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home.
A fully remote role is not possible for this position.
The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM).
This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s).
The Dir POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives.
The Dir POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment, development, coaching, mentoring, and performance management.
In a typical day, you will: Be responsible for the overall success of the clinical study team(s) within a program(s) Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development Oversee clinical study timelines within a clinical program(s) Provide input and operational insight into Clinical Study Concepts (CSC) Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies.
Ensure consistency within the program and development of best practices within CTM Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s).
Drives decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation Be responsible for direct supervision of CTM staff.
Line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.
To be considered, you must possess: A Bachelor's degree and minimum of 12 years relevant in-house sponsor-side industry experience, 8 years within clinical operations.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way.
We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.
S., the salary ranges provided are shown in accordance with U.
S.
law and apply to U.
positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency.
If you are outside the U.
S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process.
Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.
The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually) $0.00 - $0.00
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