Local Clinical Trial Manager - FSP, Germany (m/w/d)
Core
Leads local clinical study teams and manages end-to-end delivery of clinical trials within Germany, ensuring compliance with local regulations and study protocols.
Role type
Senior Local Clinical Trial Manager (FSP)
Builds
Clinical studies for pharmaceutical/biotech clients
Domain
Clinical Research / Life Sciences
Required skills
Clinical trial management, local regulatory compliance (GCP/ICH/IND), site selection and management, budget and contract management, vendor management, risk assessment and mitigation, stakeholder coordination, study documentation development, audit support
Preferred skills
Knowledge of local healthcare systems, experience with decentralized clinical trials, multilingual capabilities
Technologies
Clinical trial management systems (CTMS), regulatory submission platforms
Responsibilities
Lead local study teams and coordinate cross-functional experts; manage local study budgets, contracts, and vendor relationships; ensure regulatory compliance and submit applications to authorities; oversee site selection, monitoring, and recruitment; develop country study plans and risk mitigation strategies; manage local supply inventory and logistics; support audits and inspections.
Seniority
Senior, hands-on IC