Senior Project Coordinator
Jobgether · Allemagne
Stellenbeschreibung
About the role
We are seeking a Senior Project Coordinator to join a fast‑moving clinical research environment supporting global studies across multiple therapeutic areas. The role will coordinate site activation and study operations throughout the full clinical trial lifecycle, working closely with project managers, clinical teams, research sites and cross‑functional stakeholders.
Key responsibilities
- Coordinate and support site activation activities, ensuring timelines, quality standards and regulatory requirements are met.
- Collect, review, approve and maintain essential regulatory and clinical documentation for investigator site start‑up.
- Serve as the primary communication point between clinical sites, project teams, CRAs and external stakeholders.
- Maintain study documentation in electronic Trial Master Files (eTMF) and other project tracking systems.
- Assist with ethics submissions, study material distribution, training coordination and investigator meeting preparation.
- Monitor project timelines, site activation progress, enrollment tracking, study inventories and payment reconciliation.
- Escalate risks or delays, support issue resolution and ensure operational continuity.
- Support audits, inspections, corrective action planning and process improvement initiatives.
- Mentor junior Project Coordinators and contribute to onboarding and knowledge‑sharing activities.
Required profile
- Bachelor’s degree in clinical research, life sciences, healthcare or equivalent experience.
- Minimum 2 years of experience as a Project Coordinator or similar role in clinical research, biotech, pharmaceutical or CRO settings.
- Proven experience in site start‑up and coordination of global or multi‑regional clinical studies.
- Strong understanding of clinical trial documentation, Good Clinical Practice (GCP) and applicable regulatory requirements.
Required skills
- Electronic Trial Master File (eTMF) systems
- Project tracking systems
- Clinical trial documentation management
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Jobgether
Allemagne
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