Trial Data Manager (7105)

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Our client is headquartered in Switzerland – a biotech-hub of Europe – is a high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options is looking for a

Trial Data Manager for a initial 24 months contract based in

Basel area.

The Trial Data Manager leads end-to-end Data Management activities for assigned clinical trials, ensuring high-quality, consistent data delivery in line with internal standards, applicable regulations, and agreed timelines.

The role coordinates e CRF development, data review and query management, database lock, and SDTM-related deliverables while partnering closely with Clinical Development and other cross-functional stakeholders.

• Main responsibilities
• Lead Data Management activities for assigned clinical trials and ensure adherence to the company`s standards, applicable regulations, and study timelines.
• Provide Data Management input into clinical trial protocols and coordinate the development of electronic Case Report Forms (e CRFs).
• Author trial-specific Data Management documentation, including specifications for external data transfers, data cleaning, and review tools.
• Coordinate and track testing of e CRF screens, data-cleaning tools, and review tools through implementation in the production environment.
• Plan, monitor, and drive data cleaning, data review, query management, and database lock in collaboration with key Clinical Development stakeholders.
• Generate trial metrics and status reports, represent Data Management in Clinical Trial Team meetings, and present relevant topics at investigator and monitor meetings.
• Manage Data Management activities delivered by outsourced or insourced partners and remain accountable for quality, timelines, and deliverables.
• Ensure annotated CRFs are created, validated, and delivered according to agreed timelines, and coordinate periodic quality-control checks.
• Forecast trial-team resource requirements, ensure assigned Data Managers have the required training, and provide functional direction to colleagues supporting the same trial.
• Contribute to Data Management policies, SOPs, associated documentation, and cross-functional system or process improvement initiatives.
• Act as the Data Manager for studies where no dedicated Data Manager is assigned.

Qualifications and Experience

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
• At least
• 3 years of experience in the pharmaceutical or biotechnology industry within

Clinical Research and/or Clinical Data Management.

• Strong functional expertise in clinical data management, including clinical trial databases and applications, clinical data flow, data review, and e CRF design.
• Experience coordinating or leading Data Managers and other contributors working on the same clinical trial.
• Experience managing outsourced Data Management activities or external service partners is highly relevant.
• Good knowledge of international clinical research regulations and requirements, including ICH Good Clinical Practice (ICH/GCP).
• Ability to organize multiple deliverables, maintain oversight of timelines and quality, and communicate clear priorities.
• Confident collaboration across Clinical Development and other cross-functional stakeholder groups.
• Strong presentation and stakeholder-management skills.
• Advanced written and spoken English.
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