Clinical Data System Specialist

2 weeks ago

Bengaluru, India Tigermed India (Tigermed Clinical Research India Pvt Ltd) Full time

Location: RemoteExperience: 6+ YearsEducational QualificationsBachelor's degree or related experienceJob Purpose:This position requires the following critical abilities:Knowledge of the drug development process.6+ years’ experience in Data Management, Clinical Programming, or other Clinical Research related fields, with a minimum of 4 years’ experience in EDC programmingHands-on experience with Veeva(mandatory), Medidata Rave, Oracle Inform, etc.Experience programming in CQL, CDB, working with JSON format and/or C# is preferredExperience integrating other clinical trial modules (eg: lab, safety, IRT, coding, etc.) with the EDC systemUnderstanding of industry standard technologies to support Clinical Development needs (e.G. CTMS, SAS, R or Python, Data Warehouses, SharePoint)Manage edit check specifications and configure edit checks at the trial levelExecute UAT scripts to test the setup of the clinical study or EDC PlatformsConfigure different instances of study (eg: UAT, production, testing etc.,)Facilitate user access requests for study teamsSet up and manage blinded and unblinded study configurations in EDCServe as SME for all EDC database-related activities at the trial levelSet up, configure, validate, and integrate other modules within the EDC ecosystem

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