Abhishek Malviya
Centralized Study Specialist I
- Role
- Centralized Study Specialist i at Fortrea
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Abhishek Malviya
Currently working as a Centralized Study Specialist I at Fortrea, Bengaluru, supporting…
Experience
Centralized Study Specialist i
Dec 2024 — Present · Bengaluru, IN
Review and implementation of relevant study-specific plans that describe the required expectations for assigned tasks. Support system compliance and system data entry, as applicable. File required task-related documentation in the Electronic Trial Master File (eTMF). Develop and/or review initial/amended Core Informed Consent Forms (ICFs). Review initial/amended Country/Site ICFs in compliance with Sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines. Customize initial/amended Country/Site ICFs in compliance with Sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines. Review and approve investigator essential documents in compliance with Sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines. Perform investigator debarment /inspection listing checks. Develop and/ or review advertisements in compliance with Sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines. Support Initial/Amendment submissions to the Central IRB/IEC for North America. Create the CDA Master template and review/approval of fully executed CDAs.
Education
Government Higher Secondary School - India
12th, Biology
Manipal University Jaipur
Master of Business Administration - MBA, Project Management
Rajiv Gandhi Prodyogiki Vishwavidyalaya
Bachelor of Pharmacy - B. Pharm, Pharmacy
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