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Medical Monitor (Clinical Trials) - MBBS MD Lupin

0.0 years

0 Lacs

pune, maharashtra, india

On-site

This is a full time role based in Pune. The person will oversee medical monitoring and allied activities for clinical trials (Phase 1-4) and also support clinical development strategy function. Review study documents (Protocol, IB, ICD, SAP, , medical coding reports, CSR, etc.) Review mock and final TFLs, AE/SAE data, clinical study reports Prepare regulatory briefing documents, submission dossiers, etc. Respond to site/EC/regulatory queries Assessment of protocol deviations, assessment of ongoing safely and efficacy data, evaluation of SAEs, training of the operations team on therapy area and protocol etc. Literature search for products under evaluation for deciding strategies Support medic...

Posted 3 days ago

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