Clinical Data Manager II

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 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