Clinical Data Management SpecialistResponsibilities:Maintain and update EDC user access across multiple clinical studiesTrack and manage user access requests in coordination with CRAs and EDC vendorsCurate and maintain standardized tracking spreadsheets for both internal and external useTransfer verified data from working trackers to production master user listsRespond to and resolve user-related queries from study teams and EDC buildersPrepare and upload CDM documents to the Trial Master File (TMF) in compliance with internal SOPs and TMF standardsTrack document status and ensure completeness and accuracy of TMF contentCollaborate with Sr. CDMs to ensure documents are audit-ready and filed in a timely mannerAssist with study startup, maintenance, and closeout CDM activities as neededParticipate in team meetings, training sessions, and cross-functional collaborationSupport documentation and version control for CDM tools and templatesMaintain clear and organized records of work performedAll other duties as assignedRequirements: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 requiredAbility to perform well-defined procedures initially with supervision, and after direction is provided, work independentlyAbility to work effectively in a team-oriented environmentFlexibility to adapt to changing project requirements and timelinesExcellent attention to detail and organizational skillsStrong communication and collaboration abilitiesProficiency in Microsoft Excel, Word, and document management toolsStrong organizational skills to manage multiple tasks and projects simultaneouslyPreferred:Experience with EDC systems (e.g., Medidata Rave, Oracle InForm)Familiarity with TMF structure and regulatory filing practicesUnderstanding of GCP, GCDMP, and clinical trial workflows