Dev W.
Clinical Trial Associate @ Parexel | Clinical Study Management, eTMF
- Role
- Clinical Trial Associate Tmf Lead at Parexel
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Dev W.
With over 2 years of experience in clinical research, I am a dedicated and proficient…
Experience
Clinical Trial Associate Tmf Lead
Feb 2023 — Present · New York, NY, US
Direct the management of the Trial Master File (TMF), ensuring all quality control mechanisms are completed in a prompt manner.• Responsible for updating regulatory documents and IRB submission and approval for all sites assigned in the Trial Master File (TMF). • Updating and collecting all regulatory documents from study start up to close out (FDA 1572, FDF & Protocol Trainings)• Professional communication with CRCs on site to maintain all updated protocols and ICFs. Accountable for study level tracking as assigned by the Clinical Project Manager, e.g, monitor visit tracking and IP shipment tracking. • Working with CRAs on-site to ensure site visits are conducted following Monitoring Plan. • Provide study level information to enable accurate and efficient supply of IP to the sites. • Accountable for ensuring that agendas for meetings are clear and distributed in advance; takes comprehensive and precise meeting minutes for internal and external meetings.
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