Trial Data Manager (7105)

Lead End-to-End Data Management for Innovative Biopharmaceutical Trials

Join a high-potential biopharmaceutical company headquartered in the Basel area, a recognized European biotech hub. Specialized in the discovery, development, and commercialization of innovative small molecules, this organization is dedicated to transforming the horizon of therapeutic options. This initial 24-month contract role offers the opportunity to drive high-quality, consistent data delivery in line with internal standards, applicable regulations, and agreed timelines.

Key Responsibilities

• Lead end-to-end Data Management activities for assigned clinical trials, ensuring adherence to company standards, applicable regulations, and study timelines.
• Provide Data Management input into clinical trial protocols and coordinate the development of electronic Case Report Forms (eCRFs).
• Author trial-specific Data Management documentation, including specifications for external data transfers, data cleaning, and review tools.
• Coordinate and track testing of eCRF 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, remaining 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 eCRF 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.