Trial Data Manager

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 eCRF development, data review and query management, database lock, and SDTM-related deliverables while partnering closely with Clinical Development and other cross-functional stakeholders. - Lead Data Management activities for assigned clinical trials and ensure adherence to clients 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 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. - Master's degree in life sciences, mathematics, statistics, informatics, or a related discipline. - 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.