Supriya Chawkekar
Specialist, Study Start-up
Talent
Mumbai, MaharashtraMember since October 8, 2024
·
Hire this person
Send a job offer directly to this candidate
About
Experienced clinical research and regulatory affairs professional with a strong background in managing clinical trials, regulatory submissions, and pharmacovigilance. Seeking a challenging role to leverage my expertise in ensuring compliance and supporting the successful execution of clinical studies.
Experience
- Assisted in Health Authority submissions for Phase II & III studies in India.
- Coordinated site activities for initial Ethics Committee approvals.
- Managed and updated country and site-level documents to ensure site readiness.
- Created vendors and processed purchase orders in SAP systems.
- Communicated with local authorities on clinical trial activities.
- Managed clinical trial payments, invoices, and fund processing.
- Assisted in site feasibility and site selection during country start-up
- Coordinated with site and internal stake holder for vendor creation, fund (budget) allocation as per SOP or contract within system
- Vendor and payment set up within and for outsource system
- Assisted in agreement finalization and dispatch to site for clinical studies