Clinical Data Manager II/Senior Clinical Data Manager

Clinical Data Manager II / Senior Clinical Data Manager

Company: Precision Medicine Group
Location: UK, Poland, Hungary, Romania, Serbia, or Slovakia

Position Summary

Precision Medicine Group is seeking a Clinical Data Manager II or Senior Clinical Data Manager to join our global team. This role manages all aspects of the clinical trial data management process from study start-up to post database lock, adhering to Standard Operating Procedures (SOPs/WIs), regulatory directives, and study-specific plans. The position will also oversee and/or perform database development and testing.

Essential Functions

• Serve as the primary Data Management (DM) contact (Lead DM role) for assigned clinical projects/programs, ensuring continuity, responsiveness, and timely task completion. May support another Lead DM or oversee DM for sponsor programs.
• Oversee project data entry processes, including developing guidelines, training, ensuring quality, and managing resourcing.
• Perform quality control of data entry.
• Provide input, assess, and manage timelines, ensuring quality and timely completion of clinical data management deadlines. Assess resource needs for assigned projects.
• Develop CRF specifications based on clinical study protocols and coordinate stakeholder review.
• Conduct database build UAT, maintain quality-controlled database build documentation, and oversee overall clinical database quality.
• Specify requirements for all edit check types (electronic, manual review) and oversee development of edit check specifications.
• Create, revise, version, and maintain data management documentation, ensuring completeness for the Trial Master File.
• Train clinical research personnel on study-specific CRFs, EDC, and other project-related items.
• Review and query clinical trial data according to the Data Management Plan.
• Perform line listing data review based on sponsor and/or Lead DM guidance.
• Run patient and study-level status and metric reporting.
• Perform medical coding of medical terms to ensure medical logic and consistency.
• Coordinate SAE/AE reconciliation.
• Liaise with third-party vendors (e.g., external data and EDC vendors) in a project management capacity to support timelines and data deliverables.
• May assist with SAS programming and quality control of SAS programs used in Data Management.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and team input.
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs).
• Participate in the development and maintenance of SOPs and related process documentation for data and database management.
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, and potential client engagement meetings.
• May review RFPs, proposals, and provide project estimates.
• Provide leadership for cross-functional and organization-wide initiatives, where applicable.
• Train and ensure all data management project team members are sufficiently trained.
• Communicate with study sponsors, vendors, and project teams regarding data, database, or other project issues.
• May present software demonstrations/trainings, department/company training sessions, and present at project meetings.
• May require some travel.
• Perform other duties as assigned.

Qualifications

• Bachelor's degree and/or a combination of related experience.
• 8+ years of experience as a Sr. Clinical Data Manager or 5+ years as a Clinical Data Manager II working for a Clinical Research Organization (CRO), Pharmaceutical, or Biotech company.
• Set up and database migration experience.
• Oncology experience preferred.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Excellent organizational and communication skills.
• Professional proficiency in English (written and oral).
• Experience utilizing various clinical database management systems.
• Broad knowledge of drug, device, and/or biologic development and effective data management practices.
• Strong representational skills; ability to communicate effectively orally and in writing.
• Strong leadership and interpersonal skills.
• Ability to undertake occasional travel.