Clinical Data Manager II​/Senior Clinical Data Manager

Clinical Data Manager II / Senior Clinical Data Manager

Remote, Poland. We consider candidates based in the UK, Poland, Hungary, Romania, Serbia, or Slovakia.

This role manages all aspects of clinical trial data management from study start‑up to post‑database lock for assigned projects, following SOPs, regulatory directives, and study‑specific plans. The Clinical Data Manager II or Senior serves as Lead Data Manager for projects, drives database development and testing, and ensures compliance and quality of data management processes.

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) and program(s), ensuring continuity, responsiveness, and timely completion. May support another Lead DM as a back‑up and/or team member and may include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, quality, and resourcing.
• May perform quality control of data entry.
• Provide input, assess and manage timelines, ensuring clinical data management deadlines are met with quality and assess resource needs for assigned projects.
• May develop CRF specifications from the clinical study protocol and coordinate review/feedback from all stakeholders.
• Conduct database build UAT and maintain quality‑controlled database build documentation, overseeing overall quality of the clinical database.
• May specify requirements for all edit check types (electronic, manual data review, edit checks, etc.) and oversee development of edit check and manual data review specifications.
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation; oversee completeness of documentation for the Trial Master File.
• Train clinical research personnel on the study‑specific CRF, EDC, and other project‑related items as needed.
• Review and query clinical trial data according to the Data Management Plan.
• Perform line‑listing data review based on guidance from the sponsor and/or Lead DM.
• Run patient and study‑level status and metric reporting.
• Perform medical coding of medical terms relative to each other to ensure medical logic and consistency.
• Liaise with third‑party vendors such as external data and EDC vendors in a project‑manager capacity to support timelines and data‑related deliverables.
• May assist with SAS programming and quality control of SAS programs used in the Data Management department.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metric data, audit reports, and input from project team members and other stakeholders.
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSR) if required by the project.
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and related process documentation for data management and database management activities.
• May attend strategy meetings, bid‑defense preparation meetings, bid defenses, capability presentations, and potential client engagement meetings.
• May review Request for Proposals (RFP), 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 have been sufficiently trained.
• Communicate with study sponsors, vendors, and project teams as needed regarding data, database, or other relevant project issues.
• May present software demonstrations/trainings, departmental or company training sessions, and present at project meetings.
• May require some travel.
• Perform other duties as assigned.

• Bachelor's degree and/or a combination of related experience.
• 8+ years’ experience as a Senior Clinical Data Manager or 5+ years as a Clinical Data Manager II within a Clinical Research Organisation, 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; both written and…