Vishal R.
CLINICAL RESEARCH AND DATA MANAGEMENT
- Role
- Study Start up Associate at ICON plc
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
Experience
Study Start up Associate
Aug 2023 — Present · Bengaluru, IN
Start-up process from end to end for APAC and EU regions.• Collection of Essential documents and Preparation of IP pack. • Working on Submission phase CDA, SRQ and PIC/PIN forms and ICF Review.• Review of site level documents IRB/IEC Approval and RA Approval as per EDRR (IP and Non-IP pack) with Contracts.• Compiling Site documents and Updating IP release Form and Country documents.• Tracking and uploading Essential documents including finalized contract in PSO/CTMS and Filing in TMF/Veeva Vault.• Sanity checks, review of Approval letters with Language translation, follow up with sites for missing documents.• Aling Start Up plan resolve Sponsor IEDR queries and provide clarification as needed.• Collaboration with Sites and RSU, SAL for site activation within projected timeline.• Handled more than 50+ Sites and reviewed the IP pack and delivered Site activation within projected timeline.
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