Clinical Veeva Specialist

5 days ago

thiruvananthapuram, India beBeeVeeva Full time

Job Title: Expert Veeva EDC ProgrammerJob DescriptionThe primary objective of this role is to leverage expert-level knowledge in Veeva EDC to create, design, develop and validate clinical trial setup processes. This involves creating eCRF specifications, designing, developing and validating the clinical trial setup process with expertise in Veeva EDC.This includes setting up edit checks at the trial level to ensure data accuracy. The job also involves implementing UAT scripts to test the setup of the clinical study and identifying potential issues.Additionally, this role requires managing user accounts for study teams and configuring access controls to maintain security. It also involves configuring blinded and unblinded study configurations to ensure data integrity.Required Skills and QualificationsSubject matter expert (SME) for all EDC database-related activities, providing guidance to colleagues as needed.Ability to understand when custom functions are required within EDC systems and implement them accordingly.Capacity to troubleshoot database setup as per study needs to resolve technical issues efficiently.Strong collaboration skills to partner with team members to establish technology standards and governance models that align with business objectives.Experience in overseeing system delivery life cycle in collaboration with Clinical Operations, Clinical Supplies, IT, and Quality organizations to ensure timely delivery.Capacity to lead technology vendor oversight activities to ensure high-quality solutions and services.Ability to work closely with data engineers and data management programmers on study level integrations and deliveries to achieve project goals.Collaborative approach to avoid and resolve risks, and confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents.Participation in preparing function for submission readiness and representing Clinical Information Operations group in formal inspections or audits.Capacity to track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables, adapting to new ways of working using technology to accelerate clinical trial setup.BenefitsThis position offers a unique opportunity to leverage your expertise in Veeva EDC to drive innovation and improve clinical trial setup processes. You will have the chance to collaborate with cross-functional teams to establish technology standards and governance models that align with business objectives.OthersThis role requires a strong passion for delivering high-quality results and driving adoption of new capabilities and business processes. You will have the opportunity to contribute to the development of technology standards and governance models that support the company's business objectives.

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