Quality Management Lead for Clinical Trials
3 days ago
Quality Management and Leadership
This role involves leading and directing quality management initiatives across Global Development Quality (GDQ) systems.
The employee will provide guidance and leadership for all aspects of quality and compliance within GDQ, including risk-based quality management activities on all Regeneron-sponsored clinical trials.
This role requires collaborating with key stakeholders, building strategic partnerships, and working with study teams, relevant functions, and other GDQ functions.
The employee will manage GCP-compliant activities from a quality perspective in conjunction with the business and the GDQM (GCP) team.
This role also involves providing day-to-day quality and compliance support to cross-functional stakeholders, including issue management (triage/investigation/actions), audit responses, proactive quality management, Corrective Action/Preventive Action (CAPA) oversight, audit/issue trending.
This role requires engaging with, supporting, and liaising with multiple cross-functional stakeholders whose work impacts the GDQ system.
Participating in Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICH E6 R2.
Collaborating with Clinical Study Lead/Oversight Monitoring and CRO to monitor site level quality risks.
The ideal candidate will have a strong background in quality management, risk assessment/management, and providing GCP consultancy and support to internal and external stakeholders.
This role requires advanced knowledge and application of risk-based approaches to quality management and oversight, building fit-for-purpose quality processes in partnership with cross-functional teams and leaders.
For this opportunity, we are looking for: Bachelor's degree with a minimum of 8 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).
The ideal candidate will have a track record of success in leading quality management initiatives and improving processes.
-
Lead Statistician in Clinical Trials
23 hours ago
County Dublin, Ireland Icon Clinical Research Limited Full timeAbout This Opportunity: As a Lead Statistician in Clinical Trials, you will be responsible for planning, supervising, implementing, and monitoring the statistical processes for multiple clinical studies. You will work closely with cross-functional teams to ensure high-quality results and meet project timelines. In this role, you will leverage your...
-
Clinical Trials Biostatistics Lead
3 days ago
County Dublin, Ireland Icon Clinical Research Limited Full timeCompany OverviewICON Clinical Research Limited is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment driving innovation and excellence.We welcome candidates to join us on our mission to shape the future of clinical development.Our diverse and dynamic team is currently seeking a Principal...
-
County Dublin, Ireland Icon Clinical Research Limited Full timeWe are seeking an experienced Clinical Trial Operations Manager to join our team at Icon Clinical Research Limited.Job OverviewThis role is responsible for managing the day-to-day operations of clinical trials in the imaging and cardiac sectors.The successful candidate will be responsible for coordinating cross-functional activities, ensuring quality and...
-
Cardiac Clinical Trials Project Coordinator
3 days ago
County Dublin, Ireland Icon Clinical Research Limited Full timeWe are seeking a Cardiac Clinical Trials Project Coordinator to join our team at Icon Clinical Research Limited.Job DescriptionThe successful candidate will be responsible for supporting the management of clinical trials in the cardiac sector, including developing project plans, timelines, and budgets.This role requires strong organizational and...
-
Clinical Research Lead
3 days ago
Dublin, Dublin City, Ireland WEP Clinical Full timeAt WEP Clinical, we are seeking a highly experienced Clinical Research Lead to join our team. This key role plays a crucial part in ensuring the success of clinical trials and Expanded Access Programs (EAPs) by providing expert medical guidance and scientific oversight.About the Role:The Medical Director will serve as the primary medical and scientific...
-
Project Manager, Cardiac Trials Specialist
3 days ago
County Dublin, Ireland Icon Clinical Research Limited Full timeWe are seeking a highly skilled Project Manager to join our team at Icon Clinical Research Limited.Job DescriptionThe successful candidate will be responsible for managing clinical trials in the cardiac sector, ensuring high-quality project delivery and excellent customer satisfaction.This role requires strong leadership and communication skills, with the...
-
Clinical Trial Vendor Management Lead
1 day ago
Dublin, Dublin City, Ireland Novartis Farmacéutica Full timeJob OverviewClinical Trial Vendor Senior Managers play a crucial role in ensuring the successful delivery of global clinical trials. As a core member of the Clinical Trial Team, you will independently manage all vendor-related aspects to deliver study outcomes within schedule, quality, and performance standards.About the RoleYou will serve as the independent...
-
Clinical Trial Manager Lead
3 hours ago
Dublin, Dublin City, Ireland Icon Full timeCompany Overview:At ICON, we pride ourselves on being a world leader in clinical research. With a team of dedicated professionals, we strive to provide exceptional services that meet the evolving needs of our clients and patients.We're committed to fostering a diverse and inclusive environment where everyone feels valued and empowered to contribute their...
-
Dublin, Dublin City, Ireland Novartis Farmacéutica Full timeAbout the RoleWe are seeking an experienced professional to lead the quality assurance efforts for external service providers supporting Novartis Global Clinical Trials in R&D Quality. The successful candidate will be responsible for ensuring that our partners meet the highest standards of excellence by reviewing and approving their qualification,...
-
Clinical Trials Manager
3 days ago
Dublin, Dublin City, Ireland Healthcare Businesswomen'S Association Full timeJob Overview:Clinical Trial Vendor Associate Director is a key leadership position responsible for managing all clinical vendor-related aspects of global clinical trials. As a core member of the Clinical Trial Team, you will independently oversee study outcomes within schedule, budget, quality/compliance and performance standards.Main Responsibilities:Serve...
-
Senior Statistical Consultant
3 days ago
County Dublin, Ireland Icon Clinical Research Limited Full timeAbout ICONWe're a global leader in healthcare intelligence and clinical research. Our rich diversity makes us more innovative, enabling us to better serve our people, patients, customers, and communities.We pride ourselves on fostering an inclusive environment that drives innovation and excellence. Our mission is to shape the future of clinical...
-
Lead Biostatistician
3 days ago
County Dublin, Ireland Icon Clinical Research Limited Full timeClinical Trials ExpertiseWe are seeking an experienced Principal Biostatistician to lead statistical activities supporting our interactions with clients and regulatory agencies. The ideal candidate will have advanced knowledge of multiple statistical and therapeutic areas, the drug development process, and statistical programming practices and procedures.You...
-
Clinical Trial Management Leader
3 days ago
Dublin, Dublin City, Ireland Regeneron Ireland Dac Full timeJob SummaryThe Clinical Trial Management Leader is a key member of the Clinical Trial Management extended leadership team. Responsibilities include leading all aspects of clinical study budgets, ensuring review, presentation, and approval of initial study budget and managing the budget through the lifecycle of the program. Additionally, this role involves...
-
Quality Assurance Leader for Clinical Trials
23 hours ago
County Dublin, Ireland Regeneron Ireland Dac Full timeJob SummaryWe are seeking an experienced Quality Assurance Leader to join our team as a Senior Manager, Global Development Quality Management (GCP). This individual will provide critical guidance and leadership for all aspects of quality and compliance within Global Development Quality (GDQ) systems.In this role, you will engage with stakeholders, build...
-
Trial Protocol Expert
3 days ago
Dublin, Dublin City, Ireland WEP Clinical Full timeAbout Our CompanyWEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.Job TitleWe're looking for a highly experienced Medical Director to join our team as the primary medical and scientific expert for clinical trial protocols and Expanded Access Programs (EAPs).This role requires a...
-
Clinical Trials Manager
3 weeks ago
Dublin, Dublin City, Ireland hays-gcj-v4-pd-online Full timeYour new company Here, in Hays Life Sciences, our Multinational Clinical Trials client in Dublin is hiring a Clinical Trails Manager.The Clinical Program Manager will be a valued member of the Clinical Operations team. They will work with the Clinical Program Manager and study teams to manage global clinical trials or regional components of global clinical...
-
Clinical Trials Expert
3 days ago
Dublin, Dublin City, Ireland The RFT Group Full timeJob Overview:The RFT Group, a leading recruitment agency in the life sciences industry, is seeking an experienced Clinical Trials Expert to join our team. As a Pharmacovigilance Manager, you will play a crucial role in ensuring the safety of patients participating in clinical trials.About the Job:This is a full-time permanent hybrid role, requiring presence...
-
Laboratory Assistant I
3 days ago
Dublin, Dublin City, Ireland ICON Clinical Research Limited Full timeWe are looking for a skilled Clinical Sample Processor I to join our team at ICON Clinical Research Limited. As a Clinical Sample Processor I, you will play a critical role in the collection, processing, and tracking of clinical trial samples. This is an exciting opportunity to contribute to the advancement of innovative treatments and therapies.Main...
-
Vendor Manager Clinical Trials
3 days ago
Dublin, Dublin City, Ireland Healthcare Businesswomen's Association Full timeAbout the Job OpportunityJoin our Clinical Trials team as an experienced Associate Director. As a key member of the team, you will be responsible for managing all clinical vendor-related aspects of global clinical trials.ResponsibilitiesLead the CTT vendor sub-team, overseeing the translation of vendor-related protocol sections into external service...
-
Global Clinical Trials Manager
23 hours ago
Dublin, Dublin City, Ireland Novartis Farmacéutica Full timeJob OverviewAs a Clinical Trial Vendor Associate Director, you will be responsible for managing all clinical vendor-related aspects of global clinical trials to deliver study outcomes within schedule, quality, and performance standards.ResponsibilitiesLead the CTT vendor sub-team and collaborate with the study lead and other team members throughout the...