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AstraZeneca

Global pharmaceutical company developing prescription medicines

Local Study Associate Director - Cell Therapy

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeGermanyNo salary listedIn-person

About the Job

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, with a strong understanding of clinical study management processes in Germany.
  • Ability to prioritize 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.

Responsibilities

  • Lead Local Study Teams consisting of Clinical Research Associates and Clinical Study Assistants, coordinate activities, and optimize team performance.
  • Hold overall responsibility for country study commitments and the timely delivery of data to the required quality, budget, and timelines.
  • Provide end-to-end oversight of site identification, qualification, activation, initiation, management, and close-out.
  • Conduct Site Qualification Visits, Site Initiation Visits, routine Monitoring Visits, for-cause visits, and Close-Out Visits, as required by the study and risk-based monitoring strategy.
  • Maintain regular on-site presence at certified cell therapy centres and work closely with investigators, study coordinators, and other site personnel.
  • Identify clinical and operational risks early, agree mitigation actions with relevant stakeholders, and follow them through to resolution.
  • Lead or contribute to country and site feasibility activities and provide actionable input to study design, site selection, allocation, and recruitment forecasts.
  • Develop country-specific and site-specific recruitment and retention strategies using feasibility findings, performance data, and the local competitive landscape.
  • Ensure timely submission of required applications and documents to Ethics Committees/Institutional Review Boards and Regulatory Authorities.
  • Oversee country study budgets and support financial and contractual processes with clinical trial sites.
  • Ensure the electronic Trial Master File remains complete and inspection-ready and support audit, inspection, and final archiving activities.
  • Keep local and global stakeholders informed of progress, milestones, risks, and key delivery challenges.
  • Collaborate closely with international project teams, Medical Affairs, Site Partnerships, and other internal functions.

Desired Qualifications

  • An advanced scientific degree is advantageous.
  • 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 in developing recruitment and retention strategies is desirable.
  • Proven project, budget, risk, and stakeholder management capability.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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