Provides clinical data management support for assigned studies, including ongoing data review, discrepancy and query resolution, data cleaning, database lock activities, regulatory documentation, and user-access administration in Medidata Rave. Collaborates with clinical and analytical teams, supports system training and troubleshooting, and ensures compliance with study protocols, data management plans, SOPs, GCP, FDA, and ICH requirements.
The Senior Clinical Data Manager will provide comprehensive data management support for assigned clinical studies. The SCDM will be responsible for performing ongoing data review to ensure accuracy, completeness, and consistency of clinical trial data in accordance with the study protocol and data management plan. The CDM will have a minimum of four years of clinical data management experience, including hands-on data review experience, and demonstrated proficiency in Medidata Rave.
ResponsibilitiesClinical Data Management
- Perform ongoing review of clinical trial data to ensure accuracy, completeness, and consistency.
- Identify, investigate, and resolve data discrepancies through query management.
- Conduct manual and system-driven data reviews in accordance with study protocols and DMPs.
- Collaborate with cross-functional teams (Clinical Operations, Biostatistics, Programming, Medical Monitoring) to support data cleaning activities.
- Participate in database lock activities and ensure data readiness for interim and final analyses.
- Maintain study documentation in compliance with regulatory requirements and internal SOPs.
- Manage and maintain user access within clinical data management systems (e.g., Medidata Rave).
- Process access requests, modifications, and terminations in accordance with established procedures.
- Ensure appropriate role-based access and system permissions are assigned.
- Maintain audit-ready documentation related to user access activities.
- Support periodic access reviews and compliance checks.
- Assist with system user training and troubleshooting as needed.
Qualifications
- Bachelor’s degree in Life Sciences, Health Sciences, or a related field (or equivalent experience).
- Minimum of 4 years of clinical data management experience.
- Demonstrated hands-on data review experience in clinical trials.
Proficiency in Medidata Rave (build knowledge a plus, but not required).
- Strong understanding of clinical data management processes and regulatory requirements (GCP, FDA, ICH guidelines).
- Experience with query management and discrepancy resolution.
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