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Clinical Data Manager
vor 2 Wochen
About Debiopharm
Debiopharm International SA is a Swiss biopharmaceutical company dedicated to developing innovative therapies for patients with cancer and infectious diseases. Our unique business model focuses on bridging disruptive discovery products with international markets.
We are seeking an experienced Senior Clinical Data Manager to join our team at the forefront of clinical development.
This role offers an exciting opportunity to work on cutting-edge oncology trials, collaborating closely with cross-functional teams to ensure high-quality data delivery. Your expertise will drive the set-up, validation, and closure of clinical study databases, ensuring compliance with regulatory guidelines.
- Develop and implement data management methodologies for assigned clinical studies
- Collaborate with study teams to design and execute data management strategies
- Set up electronic Case Report Forms (eCRFs) and electronic data capture (EDC) systems
- Maintain database integrity through data validation, cleaning, and query generation
- Review technical documents including Data Management Plans and SDTM specifications
- Train study teams on data management processes and tools
- Ensure proper archiving of clinical data and monitor quality metrics
- Support audits and inspections as required
To succeed in this role, you will require:
- A strong academic background in a scientific or technical field
- Minimum 5 years of experience in clinical data management, with a proven track record in leading projects and teams
- First-hand experience in oncology trials, preferably as a lead data manager
- Proficiency with various EDC systems and related data management tools
- Excellent project management, organizational, and communication skills
- Adept at working collaboratively in a dynamic environment
- Fluency in English; proficiency in French is a plus
