Randstad UK
Clinical Trial Manager
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Global Studies Asset Manager
Location: Welwyn Garden City (Hybrid – 2 to 3 days on site per week)
Position Type: 6-Month Contract
Are you an experienced Clinical Operations professional with a strong track record in Phase 3 global trial delivery? A leading global pharmaceutical organisation is seeking a Global Studies Asset Manager (GSAM) to lead and drive operational study management across key therapeutic areas, including Oncology, Neurology, Immunology, and CVRM.
The Role
In this pivotal position, you will take ownership of the consistent and efficient operational execution of clinical studies for a specific asset portfolio. Working as a key member of the Extended Study Management Team, you will collaborate with cross-functional experts, country teams, and external partners to ensure seamless delivery.
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Key Responsibilities
- Study Execution & Oversight: Coordinate and deliver global study management aspects in full compliance with ICH-GCP and company standards.
- CRO & Vendor Management: Build strong working relationships with CRO partners and oversee 3rd-party vendor selection, setup, performance, and closeout.
- Documentation & Planning: Provide operational input into study protocols, Pharmacy manuals, and IMP management plans.
- Recruitment & Forecasting: Partner with analytics and regional teams to establish recruitment expectations and track forecasts.
- Operational Logistics: Oversee site-facing support materials, manage IMP supply and shipments, and secure clinical trial insurance.
- Risk & Quality Oversight: Track operational and quality KPIs, proactively identifying risks to timelines or quality and implementing effective mitigations.
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Essential Requirements
- Phase 3 Experience: Hands-on operational experience delivering Phase 3 clinical trials is strictly required.
- Technical Knowledge: Deep understanding of the drug development lifecycle, regulatory environments, and ICH-GCP guidelines.
- Vendor Oversight: Proven ability to manage and drive performance across global CRO and 3rd-party vendor study teams.
- Education: Degree in Life Sciences or equivalent industry experience.
- Soft Skills: Exceptional collaborative skills, adaptable in fast-paced environments, and a proactive problem-solver.
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