Clinical Data Manager II/Senior Clinical Data Manager in London

The Clinical Data Manager II/Senior Clinical Data Manager is responsible for managing all aspects of the clinical trial data management process from study start-up to post database lock for assigned projects. This includes following Standard Operating Procedures / Work Instructions (SOPs/WIs), regulatory directives, and study‑specific plans and guidelines. The role also oversees and/or performs database development, testing, and quality control.

Responsibilities

• Serve as the primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) or program(s), ensuring backup, continuity, responsiveness, and timely completion of tasks.
• Oversee project data entry, including development of data entry guidelines, training, and quality and resource planning.
• Perform quality control of data entry as required.
• Provide input, assess, and manage deadlines to ensure clinical data management milestones are met with quality; evaluate resource needs for assigned projects.
• Develop CRF specifications from the clinical study protocol and coordinate review/feedback from all stakeholders.
• Conduct database build UAT, maintain quality‑controlled database build documentation, and oversee overall database quality.
• Specify requirements for all edit check types and oversee the development of edit check and manual data review specifications.
• Create, revise, appropriately version, and maintain data management documentation; oversee completeness for the Trial Master File.
• Train clinical research personnel on study‑specific CRF, EDC, and other project items.
• Review and query clinical trial data according to the Data Management Plan.
• Perform line‑listing data reviews based on sponsor/guideline instructions.
• Run patient and study‑level status and metric reporting.
• Perform medical coding of medical terms to ensure logic and consistency.
• Liaise with third‑party vendors, such as external data and EDC vendors, in a project‑manager capacity.
• 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 using metrics, audit reports, and stakeholder input.
• Assist in reviewing and providing feedback on protocols, SAPs, and CSRs when required.
• Participate in development and maintenance of SOPs and related process documentation.
• Attend strategy meetings, bid defense preparation, capability presentations, and client engagement meetings.
• Review RFPs, proposals, and provide project estimates.
• Provide leadership for cross‑functional and organization‑wide initiatives where applicable.
• Ensure all data management project team members receive sufficient training.
• Communicate with study sponsors, vendors, and project teams regarding data and database issues.
• Present software demonstrations, trainings, and department/company sessions.
• Travel as occasionally required.
• Perform other duties as assigned.

Qualifications

• Bachelor's degree or equivalent combination of education and experience.
• 8+ years of experience as a Senior Clinical Data Manager or 5+ years as a Clinical Data Manager II in a clinical research organization, pharmaceutical, or biotech company.
• Experience in set‑up and database migrations.
• Oncology experience preferred.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Excellent organizational and communication skills.
• Professional command of the 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, oral and written communication skills.
• Strong leadership and interpersonal skills.
• Ability to undertake occasional travel.