Senior Clinical Data Manager
Vor 3 Tagen
Debiopharm is a Swiss biopharmaceutical company dedicated to research in oncology and infectious diseases to improve patient outcomes and quality of life.
We are seeking a Senior Clinical Data Manager to join our Biometry organization at our Headquarters in Lausanne.
The Senior Clinical Data Manager will be accountable for the quality and timelines of data management activities for assigned clinical studies, including studies outsourced to external providers.
The ideal candidate will ensure timely availability of complete, accurate, and consistent clinical data to support internal decision-making processes.
Key Responsibilities:
- Define and manage timelines on multiple clinical studies or development programs for Clinical Data Management.
- Coordinate/perform CDM activities for assigned studies/programs, including electronic Case Report Form design, Electronic Data Capture system set up, user acceptance testing, users training, database release, data review, and query generation and data coding.
- Prepare/review oversight plan, data management plans, data validation plans, and other study-specific procedures and guidelines in line with existing business processes and procedural documents.
- Ensure appropriate study-specific training is provided to assigned study teams and documented.
- Ensure ongoing and timely data capture and data cleaning activities, including external data sources.
- Provide/coordinate data management support to clinical study teams to keep up ongoing data review and monitoring.
- Lock, transfer, and archive clinical study databases.
- Ensure data quality is according to industry standards, and data integrity principles.
- Ensure that data management activities are compliant with GCP and applicable regulatory guidelines, processes, and Procedural documents.
- Act as a referent for transversal activities (coordination of SOP review, be the CDM representative).
Requirements:
- Scientific or technical education background, ideally university level.
- Experience of 10 years minimum in clinical data management, with strong experience using several EDC systems and related tools and technologies.
- Experience leading data management studies and teams to deliver quality databases that meet regulatory requirements.
- Good planning, organizational, and communications skills.
- Ability to effectively work and collaborate in a complex matrix organization.
- Fluent in English, good knowledge of French an asset.
Debiopharm offers a dynamic work environment, the opportunity to work on innovative medicines for patients, and a chance to be part of a successful company at the forefront of the most advanced scientific developments in the industry.
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