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Precision Medicine Group is seeking a Senior Clinical Data Manager to join their global team, supporting clinical trial operations across Eastern Europe and the UK. This role serves as the primary data management contact for assigned clinical projects, overseeing all aspects of the clinical trial data management process from study startup through post-database lock.
Key responsibilities include:
- Lead data management for assigned clinical projects/programs, ensuring backup, continuity, and timely task completion
- Oversee project data entry processes, including development of data entry guidelines, training, and quality assurance
- Manage clinical data management timelines and resource allocation to meet deadlines with quality
- Develop CRF specifications from clinical study protocols and coordinate stakeholder review/feedback
- Conduct database build UAT and maintain quality-controlled documentation
- Specify and oversee development of edit check specifications and manual data review specifications
- Create, revise, and maintain data management documentation for the Trial Master File
- Train clinical research personnel on study-specific CRF, EDC, and project-related 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 (data and EDC vendors) in a project manager capacity
- Assist with SAS programming and quality control of SAS programs
- Identify and troubleshoot operational problems based on metrics data and audit reports
- Participate in development and maintenance of SOPs and process documentation
- May attend strategy meetings, bid defenses, and capability presentations
- Provide leadership for cross-functional initiatives
- Train and ensure data management team members are sufficiently trained
- Communicate with study sponsors, vendors, and project teams regarding 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 working for a Clinical Research Organization, Pharmaceutical, or Biotech company
- Set up and database migrations experience
- Oncology experience preferred
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Excellent organizational and communication skills
- Professional use of English language, both 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 and oral/written communication skills
- Strong leadership and interpersonal skills
- Ability to undertake occasional travel
- Must be legally authorized to work in the country of employment without employer sponsorship
