Senior Clinical Data Management Specialist

4 days ago

ballari, India beBeeVeeva Full time

Job DescriptionMain Responsibilities:Create electronic case report form (eCRF) specifications, design and develop clinical trial setup processes.Develop edit check specifications and set up edit checks at the trial level.Implement user acceptance testing (UAT) scripts to test the setup of the clinical study.Configure different instances of study URLs (e.g., UAT, production, testing etc.).Set up user accounts for study teams.Manage blinded and unblinded study configurations.Serve as a subject matter expert for all electronic data capture (EDC) database-related activities.Integrate other modules within the EDC ecosystem, such as coding, integration of integrated randomization and telemetry (IRT), safety systems, local labs, etc.Understand custom functions within EDC systems.Troubleshoot database setup according to study needs.Prepare, test, and implement post-production changes as per study requirements.Collaborate with team members to establish technology standards and governance models.Oversee system delivery lifecycle in collaboration with partners.Evaluate adoption of new capabilities and business processes.Contact clinical technology vendors to ensure milestones are met.Work with leaders to resolve issues affecting clinical trials.Partner with data engineers and data management programmers on study-level integrations and deliveries.RequirementsRequired Skills and Qualifications:Educated degree in computer science or related field.Expertise in Veeva EDC programming.Experience in clinical operations, clinical supplies, IT, and quality organizations.

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