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Precision for Medicine is seeking a Clinical Data Manager II or Senior Clinical Data Manager to join its global team, supporting clinical trial operations across Europe (UK, Poland, Hungary, Romania, Serbia, Slovakia).
The role is responsible for managing all aspects of the clinical trial data management process from study startup through post-database lock. You will oversee and perform database development, testing, and quality assurance while ensuring compliance with Standard Operating Procedures, regulatory directives, and study-specific guidelines.
Key responsibilities include:
• Serve as primary Data Management contact for assigned clinical projects/programs, ensuring continuity, responsiveness, and timely task completion. May provide backup support to other Lead DMs and oversee sponsor programs.
• Oversee the project data entry process, including development of data entry guidelines, training delivery, quality assurance, and resource planning.
• Manage project timelines and assess resource needs. Ensure clinical data management deadlines are met with high quality standards.
• Develop CRF specifications from clinical study protocols and coordinate stakeholder review and feedback.
• Conduct database build UAT and maintain quality-controlled documentation. Oversee overall clinical database quality.
• Specify and oversee development of edit check specifications (electronic and manual) and manual data review specifications.
• Create, revise, and maintain data management documentation with appropriate versioning. Ensure completeness of Trial Master File documentation.
• Train clinical research personnel on study-specific CRF, EDC systems, and related project items.
• Review and query clinical trial data according to the Data Management Plan. Perform line listing data review and patient/study-level status reporting.
• Perform medical coding to ensure medical logic and consistency. Coordinate SAE/AE reconciliation.
• Liaise with third-party vendors (EDC, external data providers) in a project management capacity to support timelines and deliverables.
• Assist with SAS programming and quality control of data management programs as needed.
• Identify and troubleshoot operational problems, issues, and barriers based on metrics data, audit reports, and stakeholder input.
• Participate in protocol, SAP, and CSR review and feedback as required by projects.
This is a hands-on role combining individual contributor work with oversight responsibilities, ideal for an experienced clinical data professional ready to lead complex trial data operations.
