Clinical Data Manager Lead

Vor 4 Tagen


Lausanne, Waadt, Schweiz Debiopharm Group Vollzeit

Debiopharm Group, a privately-owned Swiss biopharmaceutical company, is committed to research in oncology and infectious diseases to improve patient outcomes and quality of life. Our unique business model acts as a bridge between disruptive discovery products and patient access in international markets.

We are seeking a Senior Clinical Data Manager to oversee the quality and progression of data management processes across clinical studies. The successful candidate will ensure timely availability of accurate, complete, and consistent clinical data to support internal decision-making while working closely with clinical trial teams.

Key Responsibilities:
  • Lead planning and execution of data management methodologies for assigned clinical studies.
  • Collaborate with study teams to implement data management strategies and practices ensuring high-quality data delivery.
  • Design and set up electronic Case Report Forms (eCRFs) and electronic data capture (EDC) systems.
  • Perform database management tasks including data validation, data cleaning, and query generation.
  • Review technical documents including Data Management Plans and SDTM specifications.
  • Coordinate and train study teams on data management processes and tools.
  • Manage the database lock process and ensure proper archiving of clinical data.
  • Monitor data quality and ensure compliance with GCP and applicable regulatory mandates.
  • Assist in audits and inspections, as applicable.

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