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About the Role

This field-based role within AstraZeneca's Cell Therapy division supports the delivery of complex cell therapy clinical studies. You will lead Local Study Teams at the country level, ensuring the timely and quality delivery of clinical studies according to budget and timelines. The position combines strategic study leadership with hands-on site management, monitoring, feasibility, recruitment, and retention.

Responsibilities

• Lead Local Study Team(s) consisting of CRA(s) and CSA(s), coordinate activities and optimise 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/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 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.

Requirements

• Bachelor's degree in life sciences, medicine or a comparable field; an advanced scientific degree is advantageous.
• 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.
• 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.
• 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.

Skills

• Clinical research
• Pharmaceutical drug development
• Clinical study monitoring
• Site qualification
• Site initiation
• Routine monitoring
• Close-out activities
• Clinical study leadership
• Local Study Team leadership
• Matrix environment
• ICH-GCP
• Local regulatory requirements
• Clinical study management processes in Germany
• Cell therapy studies (CAR-T, TCR-T, Treg)
• Clinical study feasibility
• Recruitment strategies
• Retention strategies
• Project management
• Budget management
• Risk management
• Stakeholder management
• Prioritisation
• German communication
• English communication

Location

• Field Based
• Germany

Work Type

• Field Based
• Full-time

Experience Level

• Approximately 5 years or more of experience in clinical research or pharmaceutical drug development
• Several years of hands-on clinical study monitoring experience

Education Level

• Bachelor's degree in life sciences, medicine or a comparable field
• Advanced scientific degree is advantageous

Benefits

• EGYM Wellpass
• Corporate benefits
• Additional local offerings

About the Company

• AstraZeneca's Cell Therapy division follows the science to explore and innovate, working towards treating, preventing, modifying, and even curing some of the world's most complex diseases.
• We have the potential to grow our pipeline and positively impact the lives of patients around the world.
• We are committed to making a difference and have built our business around our passion for science.
• We are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.
• A sustainable company aiming to become carbon negative across the entire value chain by 2030.

Equal Opportunity

• AstraZeneca embraces diversity and equality of opportunity.
• We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
• We believe that the more inclusive we are, the better our work will be.
• We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
• We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
• A diverse, inclusive and bias-free work environment committed to the Charta der Vielfalt, where differences are not only welcomed but actively encouraged.