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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 candidates based in the UK, Poland, Hungary, Romania, Serbia, or Slovakia.
In this role, you will manage all aspects of the clinical trial data management process from study startup through post-database lock for assigned projects. You will oversee database development and testing while adhering to Standard Operating Procedures, regulatory directives, and study-specific guidelines.
Key responsibilities include:
• Serve as the primary Data Management contact and lead 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 developing data entry guidelines, training personnel, ensuring data quality, and managing resources.
• Perform quality control of data entry and manage project timelines to ensure clinical data management deadlines are met with high quality.
• Develop CRF specifications from clinical study protocols and coordinate stakeholder review and feedback.
• Conduct database build UAT, maintain quality-controlled documentation, and oversee overall clinical database quality.
• Specify requirements for edit checks (electronic and manual), oversee development of edit check 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.
• Run patient and study-level status and metric reporting; perform medical coding to ensure logic and consistency.
• Coordinate SAE/AE reconciliation and liaise with third-party vendors (EDC, data vendors) in a project management capacity.
• Assist with SAS programming and quality control of data management programs as needed.
• Identify and troubleshoot operational problems, issues, and barriers based on metrics, audit reports, and stakeholder input.
• Participate in protocol, SAP, and CSR review and provide feedback as required.
This is a hands-on role requiring strong clinical trial data management expertise, attention to detail, and the ability to manage multiple projects and stakeholders effectively.
