Contract Clinical Study Lead

3 days ago

London, United Kingdom EPM Scientific Full time

A global specialty pharmaceutical group focused on developing and commercializing treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders, as well as healthcare solutions for the general population.

The Clinical Program Lead is responsible for activities including design, monitoring, data interpretation, and reporting related to the conduct of interventional and/or non-interventional clinical studies. Support the Director, Global Clinical Affairs in implementing the vision for Clinical Affairs to drive the quality, cost, speed, and efficiency of clinical studies delivery.
Maintain an overview of the program status and issues, proactively communicating progress, risks, issues, or changes that may impact quality, timelines, and/or budget to the Director, Global Clinical Affairs; Building expertise and staying up-to-date in the scientific aspects of the program, e.g., scientific literature review.
Protocol development and implementation of Quality by Design principles.
Study monitoring, oversight of data quality and integrity, and ensuring the safety and rights of participants.
Data management and data cleaning activities according to timelines.
Reporting, analysis review, and Clinical Study Report development.
Clinical sites: selection, contract development, budget negotiation, and monitoring; regulatory and ethics submissions requirements; supporting Clinical Study Leads/Clinical Project Associates in management and oversight.
Service providers: selection, contract development, and budget negotiation and monitoring; supporting Clinical Study Leads/Clinical Project Associates in management and oversight of activities and performance.
Implement and ensure inspection readiness within the program; support GCP audits and inspections.

This includes process enhancements, modernization of clinical trials (i.e., digital integration), and transfer of knowledge.


Provide leadership, support, feedback, coaching, and mentoring to the core Study Management Team.
Support the Director, Clinical Affairs, in professional development for the Clinical Operations Team.
Resource management within the Clinical Program, including delegation of responsibilities to project team members.
Assist in the training of relevant staff as needed.

Support the development of external communications related to clinical programs and studies.
Graduate qualifications in Biological Sciences, Nursing, Pharmacy, or Medicine (post-graduate qualifications desirable).
Working knowledge of international clinical research regulations and requirements, including ICH/GCP guidelines.
Proven experience in the management of clinical trials in the EU.
Experience in establishing and managing a clinical trial program in the EU.
Working knowledge of data management.
Project management skills.
A competitive salary with benefits.
The chance to contribute to a team whose work directly benefits healthcare and strives to improve people’s lives.
A hands-on opportunity to gain a high degree of commercial exposure.
The chance to work alongside world-leading scientific experts.
Work with highly talented and dedicated colleagues in a fast-growing company that combines a focus on cutting-edge science with commercial delivery.

  • Clinical Study Lead

    6 months ago

    London, United Kingdom hVIVO Services Limited Full time

    Overview: hVIVO conducts human challenge studies offering services to both pharmaceutical and biotechnology companies using a range of different clinical trial methods. The end goal of our clinical trials is to potentially eradicate common illnesses like the common cold and flu completely - or at least make treatment of them as easy and effective as...

  • Clinical Study Delivery Lead

    3 weeks ago

    London, Greater London, United Kingdom GSK Full time

    Job Description:We are seeking an experienced Clinical Study Delivery Lead to join our team at GSK. As a key member of our Global Clinical Delivery (GCD) team, you will be responsible for planning and leading the delivery of oncology studies to time, quality, budget, company standards, and scientific requirements.The ideal candidate will have extensive...

  • Clinical Studies Coordinator

    1 month ago

    London, United Kingdom Imperial College London Full time

    We are looking for an organised and motivated Centre Studies Coordinator with demonstrable experience of coordinating and setting up PET studies. The postholder will have working knowledge of the current legislation, and frameworks to coordinate clinical studies, and will be responsible for all aspects of study management within the Centre for Psychedelic...

  • Clinical Study Coordinator

    6 months ago

    London, United Kingdom Allen Recruitment Consulting Full time

    **Location**: London, Greater London, United Kingdom**Type**: Contract - **Job** #24625 Based in the heart of London, our client is a global pharmaceutical company focused on developing first class therapeutics. They require a **Clinical Study Codinat** with 3+ years of experience to join them on a 12-month contract to contribute to lead tasks related to...

  • Senior Manager Clinical Study Lead

    3 weeks ago

    Uxbridge, London , Uxbridge, London, London, United Kingdom Regeneron Full time

    The Senior Manager Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in...

  • Clinical Study Specialist

    3 days ago

    London, United Kingdom RBW Consulting Full time

    Freelance Clinical Research Associate Opportunity in the UK! RBW Consulting are partnered with a small European CRO seeking a dedicated Freelance CRA to collaborate with them on an exciting Duchenne Muscular Dystrophy study. This is a unique opportunity to contribute to impactful research in the field of neurology and rare diseases. Previous experience...

  • Clinical Study Specialist

    3 days ago

    London, United Kingdom RBW Consulting Full time

    Freelance Clinical Research Associate Opportunity in the UK! RBW Consulting are partnered with a small European CRO seeking a dedicated Freelance CRA to collaborate with them on an exciting Duchenne Muscular Dystrophy study. This is a unique opportunity to contribute to impactful research in the field of neurology and rare diseases. Previous experience...

  • Clinical Study Administrator

    6 months ago

    London, United Kingdom ICON plc Full time

    You will be partnering with a well-known global pharmaceutical company with a strong portfolio in Oncology trials. You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement. This program is for you if you are looking for an environment where people feel they belong and are empowered to...

  • Clinical Study Specialist

    2 days ago

    Uxbridge, London , Uxbridge, London, London, United Kingdom Regeneron Full time

    The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support...

  • Senior Clinical Study Manager

    4 weeks ago

    London, Greater London, United Kingdom BIOMARIN Full time

    Job SummaryWe are seeking a highly skilled Senior Clinical Study Manager to join our team at BioMarin. This role will be responsible for leading clinical programs across various phases, from proof-of-concept to Phase 3 and BLA/NDA/MAA filing.About UsBioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic...

  • Medical Director Clinical Study

    4 weeks ago

    London, Greater London, United Kingdom BIOMARIN Full time

    Job DescriptionBioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.We are seeking an experienced Medical Director Clinical Study to oversee clinical programs across various phases, from proof-of-concept to Phase 3 and BLA/NDA/MAA filing....

  • Clinical Site Director

    2 weeks ago

    London, Greater London, United Kingdom F. Hoffmann-La Roche Gruppe Full time

    About the RoleWe are seeking an experienced Clinical Site Director to join our team. As a Clinical Site Director, you will be responsible for overseeing the execution of clinical research studies at designated sites.Key ResponsibilitiesAct as primary contact and clinical trial expert for assigned study site personnel, providing training and technical...

  • Clinical Lead Nurse

    3 weeks ago

    London, Greater London, United Kingdom hVIVO Full time

    OverviewThis is an exciting opportunity to lead a team of experienced nurses in human challenge studies at hVIVO. As Senior Research Nurse, you will be responsible for the coordination of clinical unit activities, staff scheduling, and quality service delivery.Main Responsibilities:Lead studies from set up to close out, ensuring high standards of care and...

  • Laboratory Study Manager Lead

    4 weeks ago

    London, Greater London, United Kingdom GSK Full time

    Job OverviewGSK is a global biopharma company that unites science, technology, and talent to get ahead of disease together.About the RoleWe are seeking an experienced Laboratory Study Manager Lead to join our HBSM Central Team in London. This role will provide you with a great opportunity to be part of a core project team and take a leading role in Human...

  • EU Clinical Program Lead

    4 weeks ago

    London, United Kingdom EPM Scientific Full time

    Job Description ABOUT THE COMPANY A global specialty pharmaceutical group focused on developing and commercializing treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders, as well as healthcare solutions for the general population. ABOUT THE ROLE The Clinical Program Lead is responsible for activities including...

  • EU Clinical Program Lead

    3 days ago

    London, United Kingdom EPM Scientific Full time

    ABOUT THE COMPANY A global specialty pharmaceutical group focused on developing and commercializing treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders, as well as healthcare solutions for the general population. ABOUT THE ROLE The Clinical Program Lead is responsible for activities including design,...

  • EU Clinical Program Lead

    1 month ago

    London, United Kingdom EPM Scientific Full time

    ABOUT THE COMPANYA global specialty pharmaceutical group focused on developing and commercializing treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders, as well as healthcare solutions for the general population.ABOUT THE ROLEThe Clinical Program Lead is responsible for activities including design, monitoring, data...

  • EU Clinical Program Lead

    1 month ago

    London, United Kingdom EPM Scientific Full time

    ABOUT THE COMPANYA global specialty pharmaceutical group focused on developing and commercializing treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders, as well as healthcare solutions for the general population.ABOUT THE ROLEThe Clinical Program Lead is responsible for activities including design, monitoring, data...

  • EU Clinical Program Lead

    1 month ago

    London,, UK, United Kingdom EPM Scientific Full time

    ABOUT THE COMPANYA global specialty pharmaceutical group focused on developing and commercializing treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders, as well as healthcare solutions for the general population.ABOUT THE ROLEThe Clinical Program Lead is responsible for activities including design, monitoring, data...

  • EU Clinical Program Lead

    1 month ago

    London, United Kingdom EPM Scientific Full time

    ABOUT THE COMPANY A global specialty pharmaceutical group focused on developing and commercializing treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders, as well as healthcare solutions for the general population. ABOUT THE ROLE The Clinical Program Lead is responsible for activities including design,...