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Serve as the primary point of contact for Sponsors and internal teams regarding data management activities, including data collection, cleaning, reconciliation, delivery, database lock, and study timelines.
Collaborate with Sponsors and cross-functional teams to define and maintain Data Management Plans (DMPs) that support study requirements and deliverables.
Develop and implement data review strategies, standard and study-specific edit checks, and data processing guidelines to ensure high-quality study data.
Partner with operational teams to support study setup activities, including demographic collection requirements, visit schedules, and data collection processes.
Lead the development, review, approval, and maintenance of data transfer specifications, file requirements, and associated documentation.
Coordinate with programming teams to support data transfer requests, edit check development, and study-specific reporting requirements.
Review and validate data outputs and file formats to ensure compliance with Sponsor requirements and quality standards.
Manage database lock activities and timelines to ensure data integrity and on-time delivery of study milestones.
Act as the primary escalation point for data correction requests, data queries, and Sponsor concerns, working collaboratively with Data Coordinators, Project Managers, and operational teams to resolve issues.
Participate in the review and approval of study configurations and data management components to ensure quality study setup and execution.
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Maintain complete, accurate, and audit-ready study documentation, including Data Management Plans, data transfer specifications, reconciliation records, and Sponsor communications.
Lead routine study status meetings with Sponsors, CROs, and internal teams, including agenda preparation, meeting facilitation, and meeting minutes distribution.
Process routine data deliveries and support sample, interim, complete, and final data transfers throughout the study lifecycle.
Monitor study progress, manage priorities, and consistently deliver exceptional customer service while meeting agreed timelines and commitments.
Identify out-of-scope requests and collaborate with Project Management teams to ensure appropriate change order review and processing.
Support departmental metrics, reporting activities, process improvement initiatives, and operational excellence programs.
Verified company details for this employer are not available yet.
Full-time
Senior · 5+ years experience
Hybrid
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