Job Description

• 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.

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