Local Study Associate Director, Cell Therapy

AstraZeneca

. Lead Local Study Teams consisting of CRAs and CSAs, coordinate activities and optimise team performance .

Posted 9/22/2026full-timeRemote • GermanySeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical study management, including site qualification, initiation, monitoring, and close-out, with a strong focus on cell therapy studies. Proven ability to lead Local Study Teams, manage budgets, and ensure compliance with ICH-GCP and local regulatory requirements.

Highest-signal resume keywords

Clinical Study ManagementSite Qualification and MonitoringCell Therapy StudiesBudget and Risk ManagementBilingual Communication in German and English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchSite ActivationStudy Design InputRecruitment Strategy DevelopmentRegulatory SubmissionsETMF ManagementFeasibility AssessmentData Quality AssuranceProject ManagementClinical Trial Monitoring

Soft Skills

Team LeadershipStakeholder CommunicationProblem SolvingTime ManagementCollaboration

Certifications & Qualifications

Bachelor's Degree in Life SciencesValid Class B Driving Licence

Industry Keywords

ICH-GCPClinical TrialsPharmaceutical Drug DevelopmentCell TherapyCAR-TTCR-TTregEthics CommitteesRegulatory AuthoritiesMatrix Environment

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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