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Medical Monitor (Clinical Trials) - MBBS MD

0 years

0 Lacs

pune maharashtra india

Posted:3 days ago| Platform: Foundit logo

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Skills Required

data evaluation literature search medical coding biostatistics submission dossiers medical writing medical monitoring regulatory briefing documents clinical development strategy

Work Mode

On-site

Job Type

Full Time

Job Description

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 medical writing, data management and biostatistics teams
  • Evaluate 505(b)(2) applications, create clinical development strategy and plans for FDA, EMA, PMDA etc.

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