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Samar Patel
Specialist – Clinical Trial Coordinator (Global R&D)
Clinical Research
Samar Patel is a Clinical Research professional with 7+ years of experience specializing in Trial Master File (TMF) management, inspection readiness, and archiving operations across global clinical studies. He has led TMF oversight, compliance reviews, and automation-driven process improvements, ensuring complete and audit-ready documentation in alignment with ICH-GCP and regulatory standards.
FORMERLY AT
Merck Group
LOCATION
Mumbai
AVAILABILITY
Full Time
Skills
BMR Documentation
CTMS
ELVIS
eTMF Archiving
HPLC
Inspection Support
IR
IronMountain
RPA Initiatives
SharePoint
TMF Reconciliation
TrackWise
UV
Veeva Vault
Wingspan
+2 More
Work Experience
Senior Clinical Project Admin – Global Project Management
Covance by LabCorp
January 2021 – June 2021
- Managed TMF setup, maintenance, and audit readiness across global studies.
- Coordinated study budgets, site modifications, and data revision activities.
- Worked with CTMS reports and various tracking systems, ensuring all activities followed SOPs and timelines.
TECHNOLOGIES
CTMS, Workfront, TrackWise, Zavacor Database
eTMF QC Specialist / Clinical Documentation Specialist
Accenture Solutions Pvt. Ltd.
August 2017 – January 2021
- Performed TMF QC checks and reconciliations (CSR appendices, essential documents). Supported TMF closure and inspection readiness (MHRA, EMA).
- Handled documentation for multiple sponsors and assisted in training and process improvements
TECHNOLOGIES
Veeva Vault, ELVIS, Wingspan, TMF Reconciliation, Inspection Support
Quality Control Executive
Biocon Ltd.
July 2016 – January 2017
- Handled calibration and operation of analytical instruments.
- Managed documentation related to sampling, analysis, calibration, and BMR records
TECHNOLOGIES
HPLC, UV, IR, BMR Documentation
