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Clinical Development

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Clinical Development in Bhubaneswar, Odisha

  • Tata Consultancy Services
  • Full time
  • Email
  • Bhubaneswar, Odisha
  • 06/06/2024
  • Report

Prepares/Reviews CDP, IB, study protocols, ICF, scientific advices, TLFs and CSRs. Attends standing meetings of boards, committees, etc. as and when required. Provides/Reviews medical inputs for study conduct as per applicable GCP, SOP and regulatory requirements . Provides inputs on study level data including GCP-issues report. Attends regular meetings with CRO and/or other vendors. Supports and oversees activities of study conduct e.g. site selection, interaction with investigators and other service providers. Accountable for accuracy of trial information in all trial Registries such as Clinical Trials Registry - India (CTRI), Clinicaltrials.gov etc. Contributes to medical aspects and take part in study initiation and investigator meetings. Provides/Reviews inputs into protocol deviation decision. Oversees CRO and conducts study specific medical monitoring which includes review of daily lab alerts and SAEs to communicate with CRO regarding follow-up. Supports audits and inspections. Supports budget preparation of clinical trial (if required). Monitors safety of subjects participating in clinical trials. Supports pharmacovigilance department in preparing safety documents. Supports statistics team in the conduct of Data Safety Monitoring Board interim analysis meetings. Supports in DBL (provide inputs on Tables, Listings and Figures, participate in all DBL meetings). Prepares/Reviews CDPs, Protocol Synopsis/Protocol, IB, ICF, Safety forms etc. Reviews study documents e.g. SAP, DMP, SMP, DSMB charter, MMP, Imaging charter. Provides inputs on final TLFs, works with medical writer to review & revise CSR document, draft discussion and conclusions, participate in comment resolution meetings. Leads Regulatory and MAA approvals (USFDA/EMA/PMDA/CDSCO and other regulatory authorities across different regions and countries) for clinical aspects. Interacts with CAB/ Advisory committees/DSMB members. Supports in Handling of Regulatory, Marketing or any other molecule-related queries Medical monitoring which includes data reviews, EDC reviews. Prepares/Reviews IND / IMPD medical documents, annual updates, MAA/CTD and other regulatory submission medical documents. Supports department activities like SOP preparation and review / external potential partner scientific discussions / consultant interaction.

3 lakhs to 6 lakhs per annum



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