Clinical Trials Specialist

4 days ago

meerut, India beBeeExpert Full time

Key responsibilities include creating eCRF specifications, design, development and validation of clinical trial setup process.Edit check specifications are created and setup at the trial levelUAT scripts are implemented to test the setup of the clinical studyDifferent instances of study URL(eg: UAT, production, testing etc.,) are set upUser accounts for study teams are set up and configuredBlinded and unblinded study configurations are set up and managedThe SME for all EDC database related activities is the incumbentOther modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc. are setup, configured, validated and integratedAn understanding of when custom functions are required within EDC systems is necessaryThe ability to troubleshoot database setup as per study needs is essentialPost production changes are prepared, tested and implemented as per study needsTechnology standards and governance models are established in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizationsSystem delivery life cycle is overseen in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizationsA primary change agent to ensure adoption of new capabilities and business process is this roleClinical Technology vendors are the point of contact to ensure established milestones are met with the highest degree of qualityIssues affecting the delivery of clinical trials are resolved by working closely with leadersStudy level integrations and deliveries are performed in conjunction with data engineers and data management programmersTechnology vendor oversight activities are ledRisks are avoided and resolved through partnership with appropriate team members, technology vendors, and CRO partnersClinical Technology Trial Master File (TMF) documents are confirmed for archival and inspection readinessFunction is prepared for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or auditStudy deliverables are tracked and evaluated to mitigate risk for major data management deliverablesNew ways of working using technology to accelerate clinical trial setup are adapted to

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