Clinical Trial Manager

Position Summary:

We are seeking a highly motivated and analytical Clinical Trial Manager & RWE Specialist to join our team. In this role, you will design, implement, and analyze real-world data (RWD) studies to generate insights that inform clinical practice, market access strategies, and regulatory decision-making. Your work will bridge the gap between clinical trials and real-world patient experiences.

Key Responsibilities:

• Design and execute RWE studies (e.g. registries, observational studies, retrospective analyses) focused on Multiple Sclerosis treatment patterns, disease progression, and patient outcomes.
• Collaborate cross-functionally with medical affairs, market access, epidemiology, health economics, and regulatory teams to ensure RWE strategies align with company objectives.
• Develop protocols, statistical analysis plans, and study reports.
• Identify, evaluate, and utilize real-world data sources, including patient registries, electronic health records, and claims databases.
• Analyze and interpret complex RWD using appropriate statistical and epidemiological methods.
• Present findings internally and externally to support evidence-based decision-making, including publications and conference presentations.
• Stay current with evolving regulatory and HTA requirements related to RWE in the EU and Germany.

Qualifications:

• Master’s degree or higher in Epidemiology, Biostatistics, Public Health, Health Economics, or a related field.
• Minimum 3 years of experience in RWE generation within the pharmaceutical, biotechnology, or healthcare industry; experience in MS or neurology preferred.
• Solid understanding of study design, data analysis, and interpretation of RWD.
• Proficiency with statistical software (e.g. SAS, R, STATA) and data visualization tools.
• Knowledge of German and EU data privacy and regulatory frameworks (e.g. GDPR, BfArM guidelines).
• Excellent communication skills in German and English.