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Company Overview
A global biopharmaceutical organization is seeking a Senior Clinical Data Manager to lead and support data management activities across all stages of clinical drug development. The organization focuses on innovative therapies and collaborates with internal and external partners to ensure high-quality clinical data management standards, supporting research and regulatory compliance.
Summary
The Senior Clinical Data Manager (Sr. CDM) will lead and contribute to data management activities in support of clinical studies, ensuring data integrity, regulatory compliance, and alignment with organizational standards. This role reports to the Director of Clinical Data Management and requires collaboration across multiple internal and external stakeholders.
Key Responsibilities
Lead data management activities as the study data manager for assigned clinical trials
Oversee database build activities, including cross-functional review of eCRF content, edit check specifications, and user acceptance testing
Monitor data collection, coding, and cleaning by vendors through study metrics and targeted data reviews
Manage database lock activities and ensure proper archiving of study data
Collaborate with internal teams (Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, Regulatory Affairs) and external vendors (CROs, laboratories, and others)
Develop and execute cross-functional data review plans, coordinate data cuts/transfers, and conduct data reviews
Review CRO data management plans, CRF completion guidelines, external data transfer specifications, and other study documentation
Contribute to departmental workflows and infrastructure strategy including SOPs, templates, and preferred provider interactions
Represent data management requirements and timelines in internal and external meetings
Participate in training of external vendors and site staff
Draft and review project timelines to ensure milestones and deliverables are met
Review clinical protocols, amendments, clinical study reports, and statistical analysis plans
Support GCP inspection readiness and ensure compliance with organizational standards
Qualifications
BS/BA in a scientific discipline
Minimum 5 years of experience in a pharmaceutical, biologics, or biotechnology company
Experience in clinical drug development through Phase 3 in an outsourced CRO model; experience in rare genetic disease development preferred
Expert knowledge of eClinical processes, EDC system design/build, and other clinical trial/data management systems
Understanding of regulations and industry data standards (CDISC, SDTM, CDASH)
Experience with Oracle InForm and Medidata Rave
Proficiency with standardized medical terminology (MedDRA, WHODrug)
Skilled in MS Office Suite (Excel, Word, PowerPoint) and familiar with MS Project
Excellent written and oral communication skills
Highly motivated, flexible, with strong organizational and time management abilities
Ability to work independently and within multi-disciplinary teams
Knowledge of ICH GCP and regulatory requirements for clinical data systems including 21 CFR Part 11
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