Clinical Trial Manager

ARTO; Osterwieck; Vor Ort; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

A leading company is seeking a highly motivated Clinical Trial Manager & RWE Specialist. This role involves designing RWE studies, collaborating with cross-functional teams, and analyzing real-world data to inform clinical practice and regulatory strategies. Ideal candidates will have advanced degrees in related fields and significant experience in RWE generation, especially in Multiple Sclerosis.

Qualifikationen

• Minimum 3 years experience in RWE generation within the pharmaceutical, biotechnology, or healthcare industry.
• Experience in MS or neurology preferred.
• Excellent communication skills in German and English.

Aufgaben

• Design and execute RWE studies focused on Multiple Sclerosis treatment patterns.
• Collaborate with medical affairs, market access, and other teams.
• Analyze and interpret complex RWD using statistical methods.

Kenntnisse

Statistical analysis

Data analysis

Communication

Project management

Ausbildung

Master’s degree in Epidemiology, Biostatistics, Public Health, Health Economics, or related field

Tools

SAS

R

STATA

Jobbeschreibung

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.