Global Study Manager – FSP – EMEA

About the role

This fully client‑embedded position supports a leading bio‑pharma company and is responsible for delivering all clinical operations activities from study start through archiving. The role drives accelerated delivery plans, targets upper‑quartile performance and ensures high‑quality outcomes.

Key responsibilities

• Lead operational delivery of global clinical studies to time, quality, budget and regulatory standards.
• Develop and execute Study Initiation Meetings, Clinical Study Activity Plans, Study Delivery Plans and TMF Quality Strategy documents.
• Set up DCT infrastructure, vendor oversight plans, investigator/CRA meetings and associated training.
• Track recruitment, budgets, eTMF filing and manage vendor relationships, including CROs.
• Identify, monitor and mitigate study risks while maintaining clear stakeholder communication.
• Provide operational input to protocol, informed consent forms and other key study documents.
• Lead investigator meetings, ensure protocol compliance and maintain inspection readiness.

Required profile

• Bachelor’s degree in life sciences or related discipline.
• Minimum 5 + years of global study management experience, including Phase II‑III oncology studies.
• Proven cross‑functional leadership across regions (NA, EMEA, APAC, LATAM).
• Experience with regulatory inspections (FDA, EMA, MHRA, PMDA) is an asset.

Required skills

• eTMF and DCT platform management.
• Clinical budget and vendor (CRO) management.
• Strong knowledge of ICH/GCP guidelines and clinical systems.