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Clinical Data Manager II
Katalyst Healthcares & Life Sciences
- 🇺🇸 United States
- On-site
- Manager or above
- 8 months ago
- Excel
- Oracle
- GCP
8 months ago
- Maintain and update EDC user access across multiple clinical studies
- Track and manage user access requests in coordination with CRAs and EDC vendors
- Curate and maintain standardized tracking spreadsheets for both internal and external use
- Transfer verified data from working trackers to production master user lists
- Respond to and resolve user-related queries from study teams and EDC builders
- Prepare and upload CDM documents to the Trial Master File (TMF) in compliance with internal SOPs and TMF standards
- Track document status and ensure completeness and accuracy of TMF content
- Collaborate with Sr. CDMs to ensure documents are audit-ready and filed in a timely manner
- Assist with study startup, maintenance, and closeout CDM activities as needed
- Participate in team meetings, training sessions, and cross-functional collaboration
- Support documentation and version control for CDM tools and templates
- Maintain clear and organized records of work performed
- All other duties as assigned
- Bachelor's degree from an accredited institution with a major in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience.
- 6+ years of Clinical Data Management experience in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required
- Ability to perform well-defined procedures initially with supervision, and after direction is provided, work independently
- Ability to work effectively in a team-oriented environment
- Flexibility to adapt to changing project requirements and timelines
- Excellent attention to detail and organizational skills
- Strong communication and collaboration abilities
- Proficiency in Microsoft Excel, Word, and document management tools
- Strong organizational skills to manage multiple tasks and projects simultaneously
- Preferred :
- Experience with EDC systems (e.g., Medidata Rave, Oracle InForm)
- Familiarity with TMF structure and regulatory filing practices
- Understanding of GCP, GCDMP, and clinical trial workflows
Clinical Data Manager II · Katalyst Healthcares & Life Sciences