The Clinical Data Manager II ensures accuracy and consistency of clinical trial data while managing access in data management systems and collaborating with cross-functional teams.
The Clinical Data Manager II will provide comprehensive data management support for assigned clinical studies. The CDM 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 two years of clinical data management experience, including hands-on data review experience, and demonstrated proficiency in Medidata Rave.
ResponsibilitiesResponsibilities
Clinical 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.
User Access Management
QualificationsRequired Qualifications
- Bachelor’s degree in Life Sciences, Health Sciences, or a related field (or equivalent experience).
- Minimum of 2 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).
- Cloud Administration module experience is preferred.
- Strong understanding of clinical data management processes and regulatory requirements (GCP, FDA, ICH guidelines).
- Experience with query management and discrepancy resolution.
Cytel Waltham, Massachusetts, USA Office
1050 Winter Street, Suite 2700, Waltham, MA, United States, 02451
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