Expert Clinical Data Scientist

About the role

The Expert Clinical Data Scientist provides data management leadership across assigned clinical trials, acting as Trial Data Manager when required. The role ensures that data management processes align with the compound profile and regulatory standards.

Key responsibilities

• Lead data management activities for study start‑up, including Data Handling Plans, Data Review Plans and user acceptance testing.
• Manage local laboratory set‑up, oversee data review, SAE reconciliation and generate study status reports for trial team meetings.
• Coordinate quality activities, audit readiness, exception requests, deviations and corrective/preventive actions.
• Support junior staff, drive process improvements and lead synonym review and dictionary upgrade activities.

Required profile

• Minimum 4 years experience in drug development, with at least 3 years in clinical data management.
• Proven ability to work under pressure, lead teams and communicate effectively in a global environment.
• Excellent problem‑solving and interpersonal skills.

Required skills

• Clinical data management (CDM) tools and processes.
• Data handling plan creation, data review planning and user acceptance testing.
• Experience with laboratory data integration and SAE reconciliation.