Study Manager

K-Recruiting Life Sciences; Remote; EUR 40.000 - 60.000; Teilzeit

Zusammenfassung

A leading life sciences recruitment firm is seeking a Study Manager (M/F/D) to confirm study statuses, conduct compliance checks, and coordinate with global clinical teams. The ideal candidate has experience in real-world evidence studies, a strong understanding of regulatory guidelines, and is fluent in both English and German. This is a remote role with a capacity of one day per week for 6 months.

Qualifikationen

• Proven experience with real-world evidence and non-interventional studies.
• In-depth understanding of EMA and BfArM regulatory requirements.
• Bilingual proficiency in English and German.

Aufgaben

• Confirming the retrospective non-interventional status of studies.
• Conducting GDPR and ethics checks for research compliance.
• Preparing study documentation and protocols.
• Coordinating with clinical teams on study data.

Kenntnisse

Experience with RWE / NIS and post-approval submissions

Strong knowledge of EMA / BfArM guidelines

Fluent in English

Fluent in German

Jobbeschreibung

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