Trial Data Manager

Flexsis; Allschwil; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Zusammenfassung

Flexsis seeks a Trial Data Manager to lead end-to-end Data Management for assigned clinical trials, ensuring high-quality data delivery in line with internal standards and timelines.

You will coordinate eCRF development, data review, query management, and SDTM deliverables while partnering with Clinical Development and other stakeholders.

Qualifikationen

• 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 GCP.

Aufgaben

• 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.

Kenntnisse

Clinical Data Management

eCRF Design

Regulatory Knowledge

Project Leadership

Stakeholder Management

Quality Assurance

English Proficiency

Ausbildung

Master's degree

Jobbeschreibung

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.