Find Senior clinical data manager Jobs in County Dublin

Associate Director Inspection Management (GCP)
Regeneron —Dublin, County Dublin
- €101,500–€165,200 a year
- Management
- Supervising experience
- Presentation skills
- Annual leave
ICU; Senior Enhanced Nurse & Clinical Nurse Manager Positions
Beacon Hospital —Dublin, County Dublin
- Full-time
- Nursing
- Management
- Presentation skills
Quick apply
Principal, Global Feasibility (pre-award strategy) - Sponsor-dedicated - EMEA
サイネオス・ヘルス —Dublin, County Dublin
- Doctoral degree
- Research
- Master's degree
Senior Finance Manager - Corporate Sustainability Reporting Directive (CSRD) - 18 month contract
ICON Plc —Dublin, County Dublin
- Full-time
- Project management
- No degree
- Communication skills
- Annual leave
- Employee assistance program
Senior Manager, Core Labelling Strategy (12 month agency contract)
Viatris —Northern Cross, County Dublin
- Full-time
- Management
- Doctoral degree
- Master's degree
Laboratory Co-ordinator - External Referrals
Beacon Hospital —Dublin, County Dublin
- Full-time
- Microsoft Office
- Administrative experience
- Leaving certificate
Quick apply
13d
Senior Technical Project Manager - CMC
Sia —Dublin, County Dublin
- Full-time
- Hybrid work
- Doctoral degree
- Engineering
- English
Quick apply
Clinical Development Director - Renal
Novartis —Dublin, County Dublin
- €90,300–€167,700 a year
- Full-time
- Doctoral degree
- Writing skills
- No degree
Higher Specialist Training (HST) Team Lead
RCPI —DUBLIN 2, County Dublin
- €42,500 a year
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Annual leave
- Work from home
Quick apply
8d
EHR Medication Management Build Team Member
UPMC —Dublin, County Dublin
- Oracle
- Doctoral degree
- ERP systems
- Annual leave
7d
Senior Manager, Aggregate Reporting Management
Regeneron —Dublin, County Dublin
- €86,800–€141,200 a year
- Writing skills
- Analysis skills
- Project management
- Annual leave
1d
Quality & Continuous Improvement Lead - UPMC Sports Surgery Clinic, Dublin
UPMC —Santry, County Dublin
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Senior Clinical Engagement Project Manager
Teckro Limited —Dublin, County Dublin
- Full-time
- Hybrid work
- Project management
- Presentation skills
- Bachelor's degree
- Gym membership
- Life insurance
Quick apply
1d
Senior Manager, Financial Business Partnering
ICON Plc —Dublin, County Dublin
- Full-time
- Microsoft Excel
- Finance
- Budgeting
Senior Radiation Therapist
Blackrock Health Hermitage Clinic —Lucan, County Dublin
- Full-time
- Research
- Clinic
- Bachelor's degree
Quick apply
Discharge Coordinator
Blackrock Health Blackrock Clinic —Dublin, County Dublin
- Full-time
- Clinic
- Communication skills
- Annual leave
- Employee assistance program
Quick apply
Neurovascular Postdoctoral Researcher
National Institute for Bioprocessing Research and Training (NIBRT) —Dublin, County Dublin
- Remote
- Doctoral degree
- Research
- Analysis skills
- Annual leave
Senior Respiratory Physiologist
Beaumont Hospital —Dublin, County Dublin
- Full-time
- Bachelor's degree
- No degree
- Communication skills
CNM2 / CNS Infection Prevention & Control
Beaumont Hospital —Dublin, County Dublin
- Full-time
- Microsoft Powerpoint
- Nursing
- Microsoft Excel
12d
Neurovascular Research Fellow
National Institute for Bioprocessing Research and Training (NIBRT) —Dublin, County Dublin
- Doctoral degree
- Data analysis skills
- Research
- Annual leave

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Associate Director Inspection Management (GCP)

Regeneron -
Dublin, County Dublin

Apply Now

Job details

€101,500–€165,200 a year

Benefits

Annual leave

Qualifications

Management
Google Cloud Platform
Supervising experience
Presentation skills
Bachelor's degree

Full job description

The Associate Director, Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is a key position that is responsible for the effective management of GCP, GVP and GLP inspections. The GDQIM IML will engage with key stakeholders, build strategic partnerships working and liaising with Clinical Study teams, relevant functions and other GDQ functions to support teams with inspection preparation activities on all Regeneron-sponsored clinical trials.

In this role, a typical day might include the following:

Ensuring and managing the notification of all relevant internal and external stakeholders of upcoming and/or anticipated regulatory inspections.

Ensuring the preparation, management and integration of inspection management processes and training activities into the clinical development programs and all relevant stakeholders.
Providing effective guidance, consultancy, and support to the Clinical Study Teams (and any other key stakeholders) in advance of an impending inspection.
Assisting with the identification of opportunities to conduct mock inspections and/or Investigator Site Preparation Visits, in collaboration with the GD Quality Assurance (GDQA) team and other relevant functional groups.
Identifying and discussing with the Clinical Study Teams potential issues and/or gaps, in advance of an impending inspection, that may require strategies to mitigate risk and/or provide additional clarification to an inspector.
Ensuring the preparation, management and conduct of inspection preparation sessions which include mock inspections, trainings, and clinical site preparation visits working with GDQA team to identify and mitigate risks to clinical programs.
Serving as the back room lead/co-lead or front room co-lead, responsible for explaining, managing,and ensuring the execution of all activities, including managing the tracking of requests and inquiries, and coordinating requests for responses from relevant personnel during any regulatory inspection conducted worldwide.
Responsible for managing the preparation and provision of timely inspection updates and daily/end of inspection summaries to GD Executive and Senior Management, in addition to any other key relevant internal and external stakeholders.
Responsible for managing inspection response development, and Corrective Actions/Preventive Actions (CAPA) follow-up activities alongside other GDQIM colleagues, cross-functional stakeholders, and process owners.
Ensuring and managing the development, collection, reporting and analysis of inspection-related quality data, trends, and metrics.

This role may be for you if have:

Advanced knowledge, understanding and application of GCP, and/or GVP

guidelines including the management of significant/complex quality issues
and compliance activities.

Extensive experience with participating in, and supporting, Regulatory

Agency Inspections of Investigator Sites, Sponsors and Clinical Research
Organizations (CROs) in a GxP environment, including inspection
preparation, facilitation, and follow-up.

Effective management of interpersonal relationships, stakeholder

engagement, and collaborations.

Demonstrated ability to interface and collaborate effectively with other

Managers and Directors within, and external to, the organization.

Extensive experience in providing training and presenting information on

key quality and regulatory compliance information.

To be considered for this opportunity we are looking for:

Bachelor's degree with a minimum of 10 years of relevant
healthcare/pharmaceutical industry experience.

Experience working in either a quality/compliance role (e.g., Quality

Management, Quality Assurance etc.), or in a Clinical Development role
with expertise and/or transferable skills related to Good Clinical Practice
(GCP), and/or Good Pharmacovigilance Practice (GVP).

Experience in training, supervising, line management, mentoring and

development of staff, and leading a small team

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

€101,500.00 - €165,200.00

Apply Now

Refine Your Search

senior clinical data manager jobs in county dublin

Associate Director Inspection Management (GCP)

ICU; Senior Enhanced Nurse & Clinical Nurse Manager Positions

Principal, Global Feasibility (pre-award strategy) - Sponsor-dedicated - EMEA

Senior Finance Manager - Corporate Sustainability Reporting Directive (CSRD) - 18 month contract

Senior Manager, Core Labelling Strategy (12 month agency contract)

Laboratory Co-ordinator - External Referrals

Senior Technical Project Manager - CMC

Clinical Development Director - Renal

Higher Specialist Training (HST) Team Lead

EHR Medication Management Build Team Member

Senior Manager, Aggregate Reporting Management

Quality & Continuous Improvement Lead - UPMC Sports Surgery Clinic, Dublin

Senior Clinical Engagement Project Manager

Senior Manager, Financial Business Partnering

Senior Radiation Therapist

Discharge Coordinator

Neurovascular Postdoctoral Researcher

Senior Respiratory Physiologist

CNM2 / CNS Infection Prevention & Control

Neurovascular Research Fellow

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