Local Study Associate Director (LSAD), Cell Therapy (m/f/d) - Field Based
Core
Lead Local Study Teams to deliver complex cell therapy clinical studies across sites in Germany, ensuring compliance, recruitment, and data quality.
Role type
Senior IC clinical study manager (cell therapy)
Builds
Clinical trial sites and study deliverables for oncology cell therapy programs
Domain
Life sciences / Oncology / Cell Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Site management, feasibility analysis, recruitment strategy, risk mitigation, budget oversight, regulatory compliance (ICH-GCP), stakeholder management
Preferred skills
Cell therapy study experience (CAR-T, TCR-T, Treg), clinical study feasibility, recruitment retention strategies
Technologies
eTMF, clinical trial management systems
Responsibilities
Lead Local Study Team(s) of CRA(s) and CSA(s), conduct site qualification/initiation/monitoring/close-out visits, oversee site activation and close-out, manage country study budgets and financial processes, ensure eTMF completeness, submit regulatory applications, identify and mitigate clinical/operational risks
Seniority
Senior, hands-on IC