Clinical Data Manager II/Senior Clinical Data Manager

Clinical Data Manager II / Senior Clinical Data Manager

Join our global team as a Clinical Data Manager II or Senior Clinical Data Manager. We are open to candidates based in the UK, Poland, Hungary, Romania, Serbia, or Slovakia. You will be responsible for managing 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. This role includes overseeing and performing database development and testing.

Essential Functions:

• Serve as the primary Data Management (DM) contact for assigned clinical project(s)/program(s), ensuring back-up, continuity, and timely task performance. May support another Lead DM or oversee sponsor programs.
• Oversee the project data entry process, including guideline development, training, quality control, and resourcing. May perform quality control of data entry.
• Provide input, assess, and manage timelines, ensuring clinical data management deadlines are met with quality. Assess resource needs for assigned projects.
• May develop CRF specifications from clinical study protocols and coordinate stakeholder reviews.
• Conduct database build User Acceptance Testing (UAT) and maintain quality-controlled database build documentation. Oversee the overall quality of the clinical database.
• May specify requirements for edit checks (electronic, manual data review) and oversee the 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 for consistency and logic.
• 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.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics, audit reports, and team input.
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs).
• Participate in the development and maintenance of SOPs and related process documentation.
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, and client engagement meetings.
• May review Request for Proposals (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 study 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 occasional travel.
• Perform other duties as assigned.

Qualifications:

• Bachelor's degree or equivalent 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.
• Experience with study setup and database migrations.
• Oncology experience preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Excellent organizational and communication skills.
• Professional English language proficiency (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 and ability to communicate effectively orally and in writing.
• Strong leadership and interpersonal skills.
• Ability to undertake occasional travel.

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