Supraja Kotharu
- Role
- Clinical Project Manager i at Anika
- Location
- Chelmsford, MA, US
- LinkedIn followers
- 500 followers
About Supraja Kotharu
Experienced clinical research professional. Detail oriented and Client focused approach…
Experience
Clinical Project Manager i
Sep 2021 — Present
Prepare meeting agendas and meeting minutes. Conduct weekly team meetings and update senior management on clinical trial status. Working closely with the CRO, Monitors, and other vendors. Provide operational oversight during the trial period, plan monitoring visits, schedule meetings with CRAs, attend remote IMVs, complete IMV visit report review, and IMV & COV report template preparation. Monitor vendor activity to ensure the study is being conducted according to protocol, timelines, and within budget. Assisted with EDC soft lock. Assisted with FDA annual report and other regulatory filings top WIRB. Assist SPM with study closeout, open EDC queries, monitoring visits schedule, Monitoring report review, protocol deviations & pending action items. Clinical Trial Material shipments CTM returns & destruction.
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