Effectively support the Clinical strategy from TPP till submission of the dossier to regulatories like (FDA, EMEA, DCGI,…) in the
Prepares / Reviews CDP, IB, study protocols, ICF, briefing book for scientific advices, TLFs and CSRs
Actively work towards approaches for faster completion of trials and having a patient centric approach..
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 inputs in to protocol deviation decision.
Medical monitoring which includes data reviews, EDC reviews.
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.
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.
Prepares / Reviews IND / IMPD medical documents, annual updates, MAA / CTD and other regulatory
Supports in DBL (provide inputs on Tables, Listings and Figures, actively participate DBL meetings).
Prepares / Reviews Protocol Synopsis, Safety forms etc.
Prepare / 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.
Support Regulatory scientific meetings and MAA approvals (USFDA / EMA / PMDA / CDSCO and other regulatory authorities across different regions and countries) for clinical aspects.
Supports in Handling of Regulatory, Marketing or any other molecule-related queries
Supports department activities like SOP preparation and review / external potential partner scientific discussions / consultant interaction.
Supports in the dissemination of important scientific information through articles or presentations or training.
Performs other related duties as assigned.
Provide scientific / Medical rationale or justification on specific products or therapy area
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