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.
What We Do
Cytel enables decision-makers in the life sciences to unlock the full potential of their products. From navigating uncertainty to proving value, Cytel’s 30 years of global expertise in consulting, data-driven analytics, and industry-leading software helps biotech and pharmaceutical companies transform intelligence into confident decisions. We have an uncompromising commitment to scientific rigor and high standards of operational excellence, which are channeled through our locations in North America, Europe, the United Kingdom, and Asia. Together, we enable our clients to deliver the therapies that propel humanity forward. Cytel employs a range of data science tools from biostatistics to machine learning to help executives in the life-sciences to make confident decisions powered by data. We are probably best known for being leaders in the field of adaptive clinical trial design, a subset of trial design that uses interim looks to enhance the patient safety and commercial value of pharmaceutical products. We also have specialists in Bayesian statistics, real world evidence, artificial intelligence, health economics, and a number of other research fields to ensure that academic and scientific findings can have impact on industry quickly and seamlessly. www.cytel.com
