Senior Clinical Research Associate, CRA
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Job Description
Senior Clinical Research Associate managing clinical trial sites in Germany and ensuring compliance with GCP. Collaborating with teams to deliver innovation in cancer therapy.
Responsibilities:
- Ensure clinical trial site management and monitoring activities in compliance with GCP guidelines, applicable regulations, and SOPs
- Execute clinical monitoring activities, including qualification, initiation, routine monitoring, and close-out visits
- Maintain Investigator Site Files and Trial Master Files
- Implement site management activities in line with trial-specific functional plans
- Prepare accurate and timely visit reports
- Review trial progress (e.g., patient recruitment, data capture, issue resolution) and initiate appropriate actions
- Serve as primary contact for clinical trial supplies and other stakeholders or vendors
- Participate in clinical trial team, department and company meetings
- Contribute to the development of trial specific documents
- Contribute to the continuous improvement of Clinical Operations processes and procedures
Requirements:
- Bachelor’s degree in life sciences, nursing, or a comparable field
- 2+ years of experience in on-site monitoring (all visit types) within the pharmaceutical or biotechnology industry
- In-depth knowledge of ICH-GCP, applicable regulations, and clinical trial systems (e.g., eTMF, CTMS, EDC, IRT)
- Basic knowledge of oncology, including terminology and underlying science, is preferred
- Excellent presentation and communication skills in German and English (minimum C1 level)
- Willingness to travel up to 50-75%
Benefits:
- job bike
- job ticket
- Health Programs
- childcare benefits
- relocation allowance
- Company summer and winter events
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