Clinical Data Manager II / Senior Clinical Data Manager

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

Position Summary:
Join our global team as a Clinical Data Manager II or Senior Clinical Data Manager, responsible for managing all aspects of the clinical trial data management process from study start-up to post-database lock. You will adhere to Standard Operating Procedures/Work Instructions (SOPs/WIs) and regulatory directives, overseeing and performing database development and testing.

Essential Functions:

• Serve as the Primary Data Management (DM) contact for assigned clinical projects/programs, ensuring continuity, responsiveness, and timely task completion. May support another Lead DM as backup or team member.
• Oversee project data entry, including development of guidelines, training, quality control, and resourcing.
• Perform quality control of data entry.
• Provide input, assess, and manage timelines, ensuring clinical data management deadlines are met with quality. Assess resource needs as needed.
• May develop CRF specifications from clinical study protocols and coordinate stakeholder review.
• Conduct database build UAT and maintain quality-controlled documentation. Oversee overall clinical database quality.
• May specify requirements for edit checks (electronic, manual data review) and oversee their development.
• 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 for consistency and medical logic.
• Coordinate SAE/AE reconciliation.
• Liaise with third-party vendors (e.g., external data and EDC vendors) in a project manager capacity for timelines and data deliverables.
• May assist with SAS programming and quality control of SAS programs.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies.
• May assist in reviewing and providing feedback on protocols, SAPs, and CSRs.
• Participate in the development and maintenance of SOPs and process documentation related to data management.
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, and client engagement meetings.
• May review RFPs, proposals, and provide project estimates.
• Provide leadership for cross-functional and organization-wide initiatives.
• Train and ensure all data management project team members are sufficiently trained.
• Communicate with sponsors, vendors, and project teams regarding data, database, or other project issues.
• May present software demonstrations/trainings, department/company training sessions, and 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 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 use of the English language (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.

Additional Information:
#LI-NC1 #LI-Remote. Precision Medicine Group is an Equal Opportunity Employer. Reasonable accommodation is available for individuals with disabilities. Be aware of potential fraudulent job offers; official communication will come through the recruiting team after a formal interview process.