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 clinical study management lead (field-based)
Builds
Clinical trial data and patient access to cell therapy treatments
Domain
Biopharma / Oncology / Cell Therapy
Required skills
Clinical study monitoring, site management, team leadership, feasibility analysis, recruitment strategy, regulatory compliance (ICH-GCP), budget management, risk management
Preferred skills
Cell therapy experience (CAR-T, TCR-T, Treg), advanced scientific degree, clinical study feasibility expertise
Technologies
eTMF, Clinical Trial Management Systems
Responsibilities
Lead Local Study Team(s) consisting of CRA(s) and CSA(s); Conduct Site Qualification, Initiation, routine Monitoring, and Close-Out Visits; Maintain regular on-site presence at certified cell therapy centres; Identify and mitigate clinical and operational risks; Oversee country study budgets; Ensure timely submission to Ethics Committees/IRBs; Keep stakeholders informed of progress and risks.
Seniority
Senior, hands-on IC