Local Study Associate Director, Cell Therapy

This is a fully remote position, open to applicants in Germany.

📋 Description

• Lead Local Study Teams comprising CRAs and CSAs, coordinating activities and enhancing team performance.

• Assume overall accountability for country study obligations and ensure timely data delivery that meets quality, budget, and scheduling requirements.

• Provide comprehensive oversight of site identification, qualification, activation, initiation, management, and close-out processes.

• Conduct site qualification, initiation, routine monitoring, for-cause assessments, and close-out visits as necessary.

• Maintain a consistent on-site presence at certified cell therapy centers.

• Collaborate closely with investigators, study coordinators, and site personnel.

• Identify clinical and operational risks, establish mitigation strategies, and ensure their implementation through to resolution.

• Lead or assist in country and site feasibility assessments.

• Contribute to study design, site selection, allocation, and recruitment projections.

• Develop recruitment and retention strategies that are specific to each country and site.

• Ensure timely submission of applications and documents to Ethics Committees/IRBs and Regulatory Authorities.

• Manage country study budgets and assist with financial and contractual processes involving clinical trial sites.

• Ensure the eTMF is complete and prepared for inspections.

• Support audit, inspection, and final archiving processes.

• Keep local and global stakeholders updated on progress, milestones, risks, and delivery challenges.

• Collaborate with international project teams, Medical Affairs, Site Partnerships, and other internal departments.

⛳️ Requirements

• Bachelor's degree in life sciences, medicine, or a related field.

• Approximately 5 years or more of experience in clinical research or pharmaceutical drug development.

• Several years of practical experience in clinical study monitoring, including site qualification, initiation, routine monitoring, and close-out activities.

• Experience in leading complex clinical studies and/or Local Study Teams in a matrix environment.

• Excellent understanding of ICH-GCP and pertinent local regulatory requirements.

• Strong grasp of clinical study management processes in Germany.

• Hands-on experience in cell therapy studies, such as CAR-T, TCR-T, Treg, or similar cellular therapies, is highly preferred.

• Background in clinical study feasibility and developing recruitment and retention strategies is desirable.

• Proven ability in project, budget, risk, and stakeholder management.

• Capability to prioritize and deliver high-quality work across multiple tasks and competing deadlines.

• Excellent written and verbal communication skills in both German and English.

• Willingness and ability to travel approximately 60% of the working time, mainly within Germany, with occasional international travel and regular overnight stays.

• Valid Class B driving license.

• Advanced scientific degree is a plus.

🏝️ Benefits

• Personalized development opportunities with a strong emphasis on lifelong learning.

• A high degree of ownership, trust, appreciation, and the opportunity to contribute within a focused and passionate team.

• A diverse, inclusive, and bias-free work environment committed to the Charta der Vielfalt.

• A sustainable company aiming to achieve carbon negativity across the entire value chain by 2030.

• A comprehensive benefits package, including EGYM Wellpass, corporate benefits, and additional local offerings.