What are the responsibilities and job description for the Clinical Data Manager-II position at Katalyst CRO?
Responsibilities
- 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 timeline.
- 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.
