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.