Senior Clinical Data Manager
Debiopharm · Lausanne
Description du poste
About the role
Debiopharm is seeking a Senior Clinical Data Manager to join its Biostatistics and Data Management department at the Lausanne headquarters. You will be responsible for ensuring high‑quality, timely clinical data across multiple studies, supporting internal decision‑making and regulatory submissions.
Key responsibilities
- Lead CDM activities including eCRF design, EDC system setup, user acceptance testing and database release.
- Perform data review, query generation and coding while managing data capture from internal and external sources.
- Define and manage timelines for multiple studies, prepare Data Management Plans and validation plans in compliance with GCP, SOPs and regulatory guidelines.
- Oversee database lock, transfer and archiving, and act as a key member of the clinical study team in a matrix environment.
Required profile
- Scientific or technical university degree; project‑management certification is a plus.
- At least 10 years of clinical data management experience in the pharmaceutical industry, supporting Phase 1‑3 studies.
- Proven leadership of data‑management teams and delivery of regulatory‑compliant databases.
- Fluent English; French knowledge is an asset.
Required skills
- Strong experience with various EDC systems.
- Proficiency in automating data‑management activities with AI or digital tools.
- Solid knowledge of GCP, SOPs and regulatory requirements.
What we offer
- Opportunity to work on innovative oncology and anti‑infective programs.
- Inclusive, equal‑pay certified workplace with strong growth and collaboration culture.
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Debiopharm
Lausanne
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