Senior Clinical Data Manager

Overview

In this role you drive end-to-end clinical data management for assigned projects, from start-up to post-database lock, ensuring quality and regulatory alignment. You will serve as the primary DM contact, lead data management activities, and coordinate with sponsors, vendors, and cross-functional teams. You’ll oversee data entry, CRF specifications, database build and UAT, edit checks, and TMF documentation to support timely, compliant trial delivery. This position offers leadership opportunities within a global team and scope to influence data management strategies and SOPs. You will work in a dynamic, quality-driven environment at Precision Medicine Group, with potential travel and a focus,

Responsibilities

• Serve as lead Data Management (DM) contact for projects, ensuring back-up, continuity, and timely task execution
• Oversee data entry process, develop entry guidelines, train staff, monitor quality
• Perform data entry quality control and assess/timely manage timelines
• Draft CRF specifications from study protocol and coordinate stakeholder feedback
• Conduct database build UAT and maintain quality-controlled build documentation
• Oversee DB quality and specify/edit check requirements (electronic/manual)
• Create, revise, version, and maintain DM documentation; ensure TMF completeness
• Train study personnel on CRF, EDC, and project items
• Review and query data per Data Management Plan; perform line listing reviews
• Run patient/study metrics; generate status reports
• Coordinate SAE/AE reconciliation; liaise with external vendors in project capacity
• Assist with SAS programming and QA of SAS outputs used in DM
• Identify and troubleshoot operational issues; help review protocols/SAP/CSRs as needed
• Participate in SOP development and process documentation related to DM/db management
• Attend strategy and client-facing meetings; review RFPs and provide estimates
• Provide cross-functional leadership on initiatives; train and mentor team members
• Communicate data, database, or project issues with sponsors, vendors, and teams
• Present software demonstrations/trainings and participate in project meetings
• Possibly travel as required
• Perform other duties as assigned

Key requirements

• 8+ years’ experience as a Sr. Clinical Data Manager or 5+ years as a Clinical Data Manager II in CRO/Pharma/Biotech
• Experience with setup and database migrations
• Oncology experience preferred
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Excellent organizational and communication skills; professional English
• Experience with various clinical database management systems
• Broad knowledge of drug/biologic development and data management practices
• Strong leadership and interpersonal skills; effective written and oral communication
• Ability to travel occasionally
• Track record of meeting data management deadlines with quality

• strong leadership
• excellent communication
• problem solving
• EDC and data management systems (unspecified)
• CRF specification development
• SAS programming (may assist)

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