Job Description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Clinical Data Management based in United States. This role offers the opportunity to lead clinical data management activities across one or more studies or programs, from study start-up through database lock. You will provide strategic and hands-on oversight of data quality, database development, testing, data review, and vendor execution. Working closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, CROs, and other partners, you will help ensure reliable and inspection-ready clinical data. The role combines technical expertise with cross-functional leadership, requiring strong judgment and the ability to manage evolving priorities. You will also contribute to improving data management standards, processes, tools, and best practices across clinical programs. This is a high-impact opportunity for an experienced professional who values patient-focused execution, operational excellence, and data quality. Accountabilities: - Serve as the lead data manager for assigned clinical studies and programs, establishing study-specific data management strategies, timelines, and deliverables. - Review and approve key documentation, including Data Management Plans, Data Validation Plans, edit check specifications, eCRF specifications, and database build documentation. - Provide hands-on oversight of Medidata Rave EDC database builds, including eCRFs, edit checks, custom functions, workflows, reports, and listings. - Plan, execute, and document testing of database builds, eCRFs, edit checks, derivations, and system functionality, including defect assessment, resolution tracking, and UAT retesting. - Lead data review, query management, external data reconciliation, and database lock activities while overseeing CRO and vendor deliverables. - Monitor data quality, study metrics, and timelines to identify risks early and support external data integrations, transfer specifications, reconciliation, and inspection readiness.

- Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, CROs, and external vendors to communicate progress, risks, decisions, and timelines. - Review CRO financial reports, change notifications, and data management expenses to support scope, budget, and timeline management. - Build productive relationships across internal teams and external partners, navigating challenging situations with professionalism and a solutions-oriented mindset. - Identify opportunities to improve data management processes, standards, tools, and templates, and share best practices across clinical programs. - Ensure day-to-day decisions align with study priorities, patient safety, data quality, compliance requirements, and broader program objectives. Requirements: - Bachelor’s degree in Life Sciences, Health Sciences, Computer Science, or a related discipline; an advanced degree is preferred. - 7+ years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry. - Hands-on experience with Medidata Rave EDC, eCOA, and RTSM. - Demonstrated ability to create, run, review, and interpret Medidata Rave reports and listings for data review, cleaning, reconciliation, and oversight. - Experience testing clinical database builds, UAT scripts, edit checks, eCRFs, and database changes, including defect documentation and retesting. - Strong understanding of database design, edit checks, data review, query management, external data reconciliation, and database lock processes. - Strong knowledge of ICH-GCP and applicable clinical research regulatory requirements. - Experience reviewing CRO study finance reports, change notifications, and data management expenses.

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