Study Manager

RWE Study Manager (M / F / D)

Tasks

• Confirm retrospective non-interventional status
• GDPR + ethics check
• Determine if BfArM notification is needed
• Prepare minimal protocol + study docs
• Coordinate with global RWE / clinical team
• Review final data
• Submit simple notification if required
• Update post-marketing files (PSUR / RMP) if relevant

Qualifications

• Experience with RWE / NIS and post-approval submissions
• Strong knowledge of EMA / BfArM guidelines
• Fluent in English and German

Requirements

• Start: asap
• Duration: 6 months
• Capacity: 1 day / week
• Location: Remote

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