Clinical Trial Specialist

3 days ago


bareilly, India beBeeExpert Full time

About This RoleThis expert role will focus on creating and managing eCRF specifications, designing and validating clinical trial setup processes. The right candidate will be able to test the setup of clinical studies using UAT scripts and troubleshoot database setups as per study needs.Main ResponsibilitiesDevelop and maintain accurate and compliant eCRF specificationsCreate and implement edit check specifications at trial levelDesign and develop clinical trial setup processes for multiple studiesImplement and validate UAT scripts for clinical trialsConfigure and manage study URLs (e.g., UAT, production, testing)Set up and configure user accounts for study teamsManage blinded and unblinded study configurationsServe as the subject matter expert for EDC database-related activitiesIntegrate and configure various EDC ecosystem modules (e.g., coding, IRT, safety system, local labs)Determine when custom functions are required within EDC systemsTroubleshoot database setup issues as neededPrepare and implement post-production changes for clinical trialsCollaborate with team members to establish technology standards and governance modelsOversee the delivery life cycle of clinical trials in collaboration with Clinical Operations, Clinical Supplies, IT, and Quality organizationsPromote adoption of new capabilities and business processesWork with vendors to ensure timely delivery of clinical trialsCollaborate with data engineers and programmers on study-level integrations and deliveriesLead technology vendor oversight activitiesPartner with team members, vendors, and CRO partners to mitigate risksConfirm readiness for archival and inspection of Clinical Technology Trial Master File documentsContribute to preparing the function for submission readiness and represent the group in formal inspections or auditsTrack and evaluate study deliverables to mitigate risks for major data management deliverablesThis is a key role in accelerating clinical trial setup using technology and requires strong technical skills and experience.


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