Local Study Associate Director, Cell Therapy

🔥 9 minutes ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

😶‍🌫️ Therapist

👻 Ghost score 10%

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AstraZeneca

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 Post-IPO Debt on 2023-02

Healthcare • Biotechnology • Pharmaceuticals

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines. It primarily works in areas of oncology, cardiovascular, renal & metabolism, and respiratory diseases. With operations in over 100 countries, AstraZeneca is dedicated to scientific research and a commitment to providing effective treatments and improving patient health across a wide array of conditions.

📋 Description

• Lead Local Study Teams consisting of CRAs and CSAs, coordinate activities and optimise team performance • Hold overall responsibility for country study commitments and timely delivery of data to required quality, budget and timelines • Provide end-to-end oversight of site identification, qualification, activation, initiation, management and close-out • Conduct site qualification, initiation, routine monitoring, for-cause and close-out visits as required • Maintain regular on-site presence at certified cell therapy centres • Work closely with investigators, study coordinators and site personnel • Identify clinical and operational risks, agree mitigation actions and follow them through to resolution • Lead or contribute to country and site feasibility activities • Provide input to study design, site selection, allocation and recruitment forecasts • Develop country-specific and site-specific recruitment and retention strategies • Ensure timely submission of applications and documents to Ethics Committees/IRBs and Regulatory Authorities • Oversee country study budgets and support financial and contractual processes with clinical trial sites • Ensure the eTMF remains complete and inspection-ready • Support audit, inspection and final archiving activities • Keep local and global stakeholders informed of progress, milestones, risks and delivery challenges • Collaborate with international project teams, Medical Affairs, Site Partnerships and other internal functions

🎯 Requirements

• Bachelor's degree in life sciences, medicine or a comparable field • Approximately 5 years or more of experience in clinical research or pharmaceutical drug development • Several years of hands-on clinical study monitoring experience, including site qualification, initiation, routine monitoring and close-out activities • Experience leading complex clinical studies and/or Local Study Teams in a matrix environment • Excellent knowledge of ICH-GCP and relevant local regulatory requirements • Strong understanding of clinical study management processes in Germany • Practical experience in cell therapy studies, such as CAR-T, TCR-T, Treg or comparable cellular therapies, is strongly preferred • Experience in clinical study feasibility and developing recruitment and retention strategies is desirable • Proven project, budget, risk and stakeholder management capability • Ability to prioritise and deliver high-quality work across multiple activities and conflicting deadlines • Excellent written and verbal communication skills in German and English • Willingness and ability to travel approximately 60% of working time, primarily within Germany, with occasional international travel and regular overnight stays • Valid Class B driving licence • Advanced scientific degree is advantageous

🏖️ Benefits

• Personalised development opportunities with a strong focus on lifelong learning • A high level of ownership, trust, appreciation and room to contribute within a focused and passionate team • A diverse, inclusive and bias-free work environment committed to the Charta der Vielfalt • Sustainable company aiming to become carbon negative across the entire value chain by 2030 • Comprehensive benefits package, including EGYM Wellpass, corporate benefits and additional local offerings