Clinical Development

· 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.