Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
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.
Requirements:
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.