Study Manager - FSP - EMEA
Core
Oversees end-to-end operational delivery of clinical studies, ensuring inspection readiness, managing study teams, and driving continuous improvement in operational efficiency.
Role type
Senior Clinical Study Manager (IC)
Builds
Clinical study delivery across all phases and therapeutic areas
Domain
Pharmaceutical / Clinical Trials
Deliverable
client delivery
Required skills
Clinical study management, Vendor/CRO oversight, Budget management, Risk management, Protocol development, Regulatory compliance (ICH-GCP), Project management, Data oversight (eTMF), Team mentoring
Preferred skills
Agile/Scrum methodology, Financial analysis, Cross-functional stakeholder management, Change management
Technologies
Clinical Trial Management Systems (CTMS), Trial Master File (TMF), Microsoft Office (Advanced Excel)
Responsibilities
Monitor study conduct and escalate risks, Review clinical documents and lead study plan development, Manage vendor relationships and CRO deliverables, Oversee clinical supplies and investigational products, Ensure eTMF completeness and inspection readiness, Manage study budgets and task orders, Mentor less experienced colleagues
Seniority
Senior, hands-on IC with mentorship responsibilities
