Local Study Associate Director (LSAD) / Clinical Project Lead - Zelltherapie (Innendienst) (m/f/d)

We are looking for one/n in our Hamburg location Local Study Associate Director (LSAD) / Clinical Project Lead (m/w/d) As a Local Study Associate Director (LSAD) (m/w/d) in the field of cell therapy, you take over the management of local study teams (LSTs) at country level and are responsible for the planned implementation of agreed components of clinical studies in the context of the defined resources, budgets and timetables. You ensure compliance with AZ procedural documents, international guidelines (e.g. ICH-GCP) as well as relevant local regulations, thereby introducing your expertise in cell therapy studies. To support our flexible capacity model, you can carry out site monitoring (monitoring) if necessary. In addition, you are responsible for ensuring that study sites in cell therapy are managed professionally throughout the entire life cycle: from identification to qualification, setup and initiation to monitoring, completion and proper archiving of the documentation. Influence: Head of the local study team: You conduct CRAs and CSAs, coordinate their tasks and ensure efficient cooperation. Location management over the entire study cycle: from the selection and qualification of the test centres to the initiation, monitoring and completion of the study. Regulatory and financial compliance: You take care of the submission of documents to authorities and ethics committees, the creation of consent declarations and the correct budget management. Quality and risk management: You ensure compliance with ICH-GCP, AZ-SOPs and local regulations, identify risks early and develop solutions. Communication and reporting: You keep global and local stakeholders informed about progress, milestones and challenges and contribute to the strategy for patient recruitment.

Strengths prove: Completed scientific/medical studies or comparable At least 5 years of experience in clinical research, preferably with well-founded knowledge in the monitoring of clinical trials in the field of cell therapy (e.g. CAR-T, TCR-T, Treg) - ideally including conducting such studies. Experience in project management and the management of complex study processes and the resulting setting of the right priorities Very good process knowledge in carrying out clinical studies, especially in Germany Excellent ICH-GCP knowledge and comprehensive understanding of relevant laws (AMG) and regulatory requirements Very good knowledge of German and English in word and writing Embossed team skills and communication strength, especially in virtual environments, as well as the ability to motivate and develop local study teams High readiness for adaptation and change as well as analytical and strategic thinking readiness to travel in Germany and abroad incl. Overnight stay

It offers: an attractive pipeline and innovative products individual development opportunities and the focus on lifelong learning lots of trust, appreciation and space for co-design in a focused and passionate team Office space in the heart of Hamburg, which enables collaborative, flexible and agile cooperation a diverse, inclusive and prejudice-free working environment, committed to the Charter of Diversity, not only allows differences, but actively promotes and welcomes and takes into account applications from all qualified applicants, regardless of their characteristics a sustainable company that becomes CO2 negative by 2030 along the entire value chain Please submit a full application consisting of letters, CV and relevant certificates. In the CV, the experience in cell therapy should be clearly and structured. .