Indu Prashanth
Lean Six Sigma Green Belt | Project Management | Total Quality Management
- Role
- Senior Officer - Clinical & Medical Affairs at Hetero
- Location
- Hyderabad, IN
- LinkedIn followers
- 500 followers
About Indu Prashanth
Experienced Clinical Research Associate with a demonstrated history of working in the…
Experience
Senior Officer - Clinical & Medical Affairs
Jun 2023 — Present · Hyderabad, IN
Handled various projects of phase – I & II clinical trials of New Chemical Entity (NCE)- In coordination with the project manager, provide oversight of all study-related activities (overall study management) and take a lead role where required- Maintain audit readiness at the site level- Assist project manager in the development of SOPs, and various tools plans, manuals, presentations, Forms and logs, and trackers for the study- Assist project manager in conducting site audits for Biologics team and Generic team to ensure their compliance with protocol, GCP, and applicable regulatory requirements- Assist project manager in conducting vendor evaluation activities for outsourcing various activities i.e, Clinical Trial Monitoring, Clinical Data Management, Central Lab, Medical Writing & Logistics activities.
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