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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