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As part of the Clinical Development Department, the Head of Data Management coordinates all clinical data management activities for Bioprojet’s clinical development programs and related regulatory submissions. They manage the Data Managers team, supervise vendors, and ensure the highest quality of collected clinical data, within budget and timelines.

Main activities :

• Manage the Data Managers team (3 people).
• Supervise and guide Data Managers in their tasks.
• Plan training for Data Managers.
• Proactively contribute to organizational strategy and implement changes within the department.
• Coordinate the implementation of processes to ensure consistency and reliability of clinical data.
• Independently lead the management of all data management deliverables for the company’s clinical studies in coordination with internal and external teams.
• Provide expertise in data management for coordinating, collecting, and cleaning data to ensure the collection and production of high-quality clinical data.
• Perform data management activities.
• Develop and manage data management timelines to meet program objectives and activities.
• Support the Data Managers team in the operational monitoring of clinical studies.
• Anticipate stakeholder obstacles and issues and act accordingly to achieve team objectives.
• Ensure completeness, accuracy, and consistency of clinical data and data structure for all projects on an ongoing basis.
• Ensure that data management deliverables meet project/study team expectations in terms of quality, timelines, and cost, and that data management documentation is filed/archived.
• Supervise data management CROs and other third-party vendors to ensure compliance with the protocol, external and internal standards, GCP, and applicable regulatory guidelines.
• Lead and contribute to the creation and review of data management SOPs and related documents.
• Represent data management during internal audits and inspections.
• Ensure that the data collection and processing systems used are validated.
• Proactively contribute to continuous improvement activities within clinical data management.
• Participate in drafting regulatory documents (Annual Safety Reports, Investigator’s Brochure, etc.).
• Coordinate, manage, and source consultants/service providers for Data Management and participate in the management of Biostatistics consultants/service providers.
• Contribute to the qualification of these providers and to audits for Data Management activities.
• Manage specialized tool vendors (SAS®, CDMS, etc.).
• Participate in drafting study protocols and statistical analysis plans with project teams and any service providers.
• Ensure database security.
• Develop and monitor the Data Management Department budget.
• Stay up to date on technological developments, methods, and regulatory changes relevant to clinical data management.

Recruiter Contact

Email : job@bioprojet.com

Position to be filled by October 1, 2025, at the latest.