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Data consultant • basel

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Trial Data Manager

FlexsisAllschwil, Basel-Landschaft, Switzerland, Basel-Landschaft

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 coord... Mostra di più

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Trial Data Manager

Trial Data Manager

FlexsisAllschwil, Basel-Landschaft, Switzerland, Basel-Landschaft
1 giorno fa
Descrizione dell’offerta di lavoro

Functieomschrijving

Description of the company

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.

Role & Responsibilities

  • 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.

Candidate Profile

  • 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.