Study Manager
Posted 2 hours 22 minutes ago by Adecco
Study Manager
Location: Welwyn Garden City
Contract Length: 12 months
Daily Rate: £377.54 - £550.00 (insideIR35
Our client, a leading pharmaceutical organisation, is seeking an experienced Study Manager to join their Clinical Operations team in Welwyn Garden City. This is an excellent opportunity for a clinical research professional with experience managing early-phase clinical trials to contribute to the successful delivery of innovative studies that support the development of new treatments.
Key Responsibilities:
- Support the planning, execution, and delivery of early-phase clinical studies, ensuring adherence to regulatory requirements, GCP, and company standards.
- Coordinate study timelines, resources, and operational activities to support successful study delivery.
- Collaborate with cross-functional stakeholders, including Clinical Operations, Data Management, Regulatory Affairs, and external partners.
- Support country and site feasibility assessments, study start-up activities, and participant recruitment efforts.
- Oversee study documentation and systems, including informed consent forms, communication plans, monitoring plans, and Trial Master Files (TMF).
- Support the selection, management, and oversight of vendors and third-party suppliers to ensure quality and timely delivery of services.
- Identify, assess, and mitigate study risks while maintaining study action and decision logs.
- Contribute to process improvements and operational excellence initiatives across Clinical Operations.
Qualifications:
- Degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline.
- Experience managing or coordinating clinical studies within a pharmaceutical, biotechnology, or CRO environment.
- Experience supporting Phase I and/or Phase II clinical trials.
- Strong understanding of ICH-GCP, clinical research regulations, and study management processes.
- Experience working with cross-functional teams and external vendors.
- Knowledge of study start-up activities, feasibility assessments, and site management.
- Excellent project management, communication, and stakeholder management skills.
- Proficiency with clinical trial systems, TMF management, and Microsoft Office applications.
Application Process:
Interested candidates are invited to submit their CV outlining their relevant experience and suitability for the role.
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