Clinical Data Management Specialist

Job descriptionTCS is hiring forClinical Data Management Job LocationMumbai Experience Range –7 to 12 Years Skillset Required- Knowledge of medical device risk classification Education UG:B.Pharma in Any Specialization PG:M.Pharma in Any Specialization, MS/M.Sc(Science) in Any SpecializationInterested candidates are requested share updated CV with below details on the mail id – s.laharika@Key Responsibilities Review and understand the study protocol and the timelines. Perform data review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Implement study team feedback as required on the data. Perform external checks to handle manual discrepancies and action the same. Develop specifications, implementation and testing for the edit checks and listings (DVS) Perform UAT for database Develop study specific procedures documents Ensure effective implementation of standard metric and status reporting on the study Ensure an error free, quality data with no open queries. Maintain data management study files and documentation Attend and provide an update for data management services at cross-functional study team meetings both internally and with the sponsor Identify out of scope tasks and bring to the attention of the TDM Assist the TDM in all study set up activities. Provide all study related reports to the TDM as per the request . . Perform SAE reconciliation and Vendor data reconciliationRegards, Laharika-TCS HR

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