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Salary: PLN 190,200 - 285,400 / annual
Precision Medicine Group is seeking a Senior Clinical Data Manager to join their global team, supporting clinical trial operations across Central and Eastern Europe (Poland, Hungary, Romania, Serbia, or Slovakia).
You will serve as the primary data management contact for assigned clinical projects and programs, managing all aspects of the clinical trial data management lifecycle from study startup through post-database lock. This is a leadership role within the data management function, with responsibility for overseeing data entry processes, database development, quality control, and cross-functional coordination.
Key responsibilities include:
- Lead data management for assigned clinical projects, ensuring continuity, responsiveness, and timely task completion; may support other Lead DMs as backup
- Oversee data entry processes including development of guidelines, training, quality assurance, and resource planning
- Conduct database build UAT and maintain quality-controlled documentation; oversee overall database quality
- Develop CRF specifications from clinical protocols and coordinate stakeholder review/feedback
- Specify and oversee development of edit check specifications and manual data review specifications
- Create and maintain data management documentation; ensure Trial Master File completeness
- Train clinical research personnel on study-specific CRF, EDC, and related systems
- Review and query clinical trial data per Data Management Plan; perform line listing reviews
- Perform medical coding and coordinate SAE/AE reconciliation
- Liaise with third-party vendors (EDC, data vendors) in project manager capacity
- Assist with SAS programming and QC of data management programs
- Identify and troubleshoot operational issues using metrics, audit reports, and stakeholder input
- Participate in SOP development and maintenance for data and database management
- May attend strategy meetings, bid defenses, and client engagement meetings
- May review RFPs, proposals, and provide project estimates
- Provide leadership for cross-functional initiatives
- Communicate with sponsors, vendors, and project teams on data and database issues
- May present software demonstrations and training sessions
- May require occasional travel
Requirements:
- Bachelor's degree and/or combination of related experience
- 8+ years' experience as a Senior Clinical Data Manager OR 5+ years as a Clinical Data Manager II with a Clinical Research Organization, Pharmaceutical, or Biotech company
- Database setup and migration experience
- Oncology experience preferred
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Excellent organizational and communication skills
- Professional English language proficiency (written and oral)
- Experience with various clinical database management systems
- Broad knowledge of drug, device, and/or biologic development and effective data management practices
- Strong leadership and interpersonal skills
- Ability to undertake occasional travel
