Clinical Data Manager II / Senior Clinical Data Manager

The role is for a Clinical Data Manager II or Senior Clinical Data Manager to oversee all aspects of clinical trial data management from start-up to post database lock, supporting projects in the pharmaceutical or biotech industry.

Location: UK, Poland, Hungary, Romania, Serbia, Slovakia

Responsibilities

• Manage all aspects of the clinical trial data management process from study start up to post database lock.
• Oversee and perform database development and testing.
• Serve as the primary Data Management contact for assigned projects.
• Oversee project data entry process, including development of data entry guidelines, training, and quality control.
• Provide input on timelines and resource needs.
• Develop CRF specifications and coordinate review/feedback.
• Conduct database build UAT and maintain documentation.
• Specify requirements for edit checks and oversee their development.
• Create, revise, and maintain data management documentation.
• Train clinical research personnel.
• Review and query clinical trial data.
• Perform line listing data review.
• Run patient and study level status reports.
• Perform medical coding of medical terms.
• Coordinate SAE/AE reconciliation.
• Liaise with third-party vendors.
• Assist with SAS programming and quality control.
• Identify and troubleshoot operational problems.
• Review protocols, SAPs, and CSRs.
• Participate in SOP development.
• Attend strategy and client meetings.
• Review RFPs and proposals.
• Provide leadership for initiatives.
• Train project team members.
• Communicate with sponsors, vendors, and project teams.
• Present software demonstrations and training.
• Travel as needed.
• Perform other duties.

Requirements

• Bachelor's degree or related experience.
• 8+ years’ experience as a Senior Clinical Data Manager or 5+ years as a Clinical Data Manager II.
• Experience with setup and database migrations.
• Oncology experience preferred.
• Proficiency in Microsoft Office.
• Excellent organizational and communication skills.
• Professional English language skills.
• Experience with clinical database management systems.
• Broad knowledge of drug, device, or biologic development.
• Strong communication, leadership, and interpersonal skills.
• Ability to undertake occasional travel.