Senior Clinical Data Manager

Overview

In this role you will lead and manage the clinical data management process across trials from start-up to post-database lock, ensuring quality and regulatory alignment. You will collaborate with cross-functional teams to develop data collection and quality controls, oversee database development and testing, and mentor the data management team. The position offers impact through driving data integrity, timelines, and strategic input on protocols, SAPs, and CSRs. This is a senior, leadership-focused opportunity within a global clinical data management function.

Responsibilities

• Serve as the primary DM contact (Lead DM) for assigned projects with back-up coverage
• Oversee data entry processes, guidelines, quality, and resource planning
• Perform QC of data entry and ensure on-time DM deliverables
• Develop CRF specifications from protocol and coordinate stakeholder feedback
• Lead database build UAT and maintain DB build documentation
• Specify and oversee edit checks and data review processes
• Maintain and version DM documentation and Trial Master File completeness
• Train site personnel on CRF/EDC and project items as needed
• Review data per Data Management Plan and conduct line listing reviews
• Generate study-level and patient-level status reports and metrics
• Perform medical coding to ensure data logic and consistency
• Coordinate SAE/AE reconciliation and vendor interactions
• Assist with SAS programming and QC of SAS programs in DM
• Identify operational issues and propose solutions using metrics and stakeholder input
• Participate in protocol/SAP/CSR review when required
• Support SOP development and process documentation for DM and database management
• Engage in strategy meetings, client engagements, and bid-related activities
• Provide leadership for cross-functional initiatives and data management training
• Communicate with sponsors, vendors, and project teams on data and DB issues
• Present software demos or trainings as needed
• Travel as required
• Perform other duties as assigned

Key requirements

• 8+ years’ experience as Sr. Clinical Data Manager or 5+ years as CDM II in CRO/pharma/biotech
• Database setup and migration experience
• Oncology experience preferred
• Proficiency in Microsoft Office
• Excellent organizational and communication skills
• Professional English (written and oral)
• Experience with various clinical database management systems
• Broad knowledge of drug/device/biologic development and data management practices
• Strong leadership and interpersonal skills
• Ability to travel occasionally
• Legal authorization to work in country of employment without sponsorship

• strong communication skills
• leadership and interpersonal abilities
• organization and attention to detail
• EDC and CRF specification development
• Clinical data management systems experience
• Edit check specification development

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