Job Title: Director Program - Clinical Data Management (CDM)

Division / Function: Data Management, Standards & Systems / Global Biometry

Manager's Job Title: Head of Data Management, Standards & Systems

Location: Paris, France

Role Summary:

The Director Program - Clinical Data Management (CDM) is responsible for defining and overseeing the implementation of the Data Management strategy for an Asset/Therapeutic Area within 's portfolio. This includes ensuring high-quality data management practices, compliance with regulatory requirements, and efficient resource management. The role involves coordinating with external vendors, managing budgets, and ensuring data consistency across studies.

Key Responsibilities:

• Strategy & Oversight: Define and implement a robust data management strategy for development programs, ensuring alignment with standards and regulatory requirements.
• Operational Excellence: Manage data management activities from protocol review to data submission, ensuring high-quality data collection, processing, and reporting.
• Vendor Management: Oversee and evaluate external vendors, ensuring deliverables meet project expectations for quality, budget, and timelines.
• Team Leadership: Provide functional and hierarchical management of the Clinical Data Management team, including recruitment, talent development, and performance appraisal.
• Process Improvement: Lead the implementation of data quality systems, stay updated with new technologies, and drive continuous improvement initiatives.
• Compliance & Reporting: Ensure compliance with internal standards and regulatory requirements, monitor data quality, and report on project status to stakeholders.

Essential Qualifications:

• Experience: 8-15 years in a similar position with proven project management skills in data management activities at a development program level.
• Skills: Strong technical understanding of clinical database structures, project planning, risk management, and excellent communication and organizational skills.
• Education: Life Science and/or Information Technology graduate.
• Languages: Proficiency in English; French is preferred.

Preferred Qualifications:

• High knowledge of international standards (ICH, GCP, CDISC) and experience managing relationships with Service Providers.
• Understanding of the drug development process and budget management.
• Ability to work effectively within multidisciplinary teams.

Additional Information:

• Conduct activities in accordance with rules and values.
• Participate in continuous improvement and environmental impact reduction initiatives.
• Provide expertise in the development of department SOPs and working procedures.

This role is integral to ensuring the success of 's clinical data management and the timely delivery of high-quality data for regulatory submissions.