Clinical Data Management Lead

5 days ago


coimbatore, India beBeeExpertise Full time

Senior Clinical Technology SpecialistJob DescriptionWe are seeking a highly skilled Senior Clinical Technology Specialist to lead the implementation of clinical trial technology solutions. As a key member of our team, you will be responsible for designing, developing, and validating eCRF specifications, as well as setting up and configuring edit checks at the trial level.Required Skills and QualificationsDevelop UAT scripts to test the setup of the clinical study.Set up different instances of study URLs (e.g., UAT, production, testing etc.) and configure user accounts for study teams.Manage blinded and unblinded study configurations and serve as the SME for all EDC database related activities.Understand when custom functions are required within EDC systems and implement them accordingly.Troubleshoot database setup as per study needs and collaborate with data engineers and data management programmers on study level integrations and deliveries.Partner with appropriate team members to establish technology standards and governance models.BenefitsThis role offers a unique opportunity to work closely with cross-functional teams, including Clinical Operations, Clinical Supplies, IT, and Quality organizations, to oversee system delivery life cycles and ensure seamless adoption of new capabilities and business processes.OthersLead technology vendor oversight activities and partner with vendors to ensure established milestones are met with the highest degree of quality.Collaborate with leaders to resolve issues affecting the delivery of clinical trials and confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents.Represent the organization in formal inspections or audits and participate in preparing function for submission readiness.


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