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Jitesh Rathod

@jiteshrathod

Quality Specialist at IQVIA RDS, investigating clinical-trial quality issues and developing CAPAs.

At IQVIA RDS (India) Pvt. Ltd., I investigate deviations, non-compliance, quality issues, potential serious breaches, and customer complaints for Eli Lilly and cFSP Boehringer Ingelheim. I perform root cause analysis and develop, implement, and monitor CAPAs.

At COD Research Pvt. Ltd., I oversaw the Quality Management System and planned and conducted audits across investigator sites, systems, strategic partners, and vendors. I also reviewed study documents for compliance and supported sponsor and regulatory audits.

At Veeda Clinical Research Ltd., I conducted GxP, site, vendor, alliance, and system audits, and supported investigation reviews and trend analysis. My work there was recognized with an innovation award and a key contribution award.

Earlier, I supported clinical trial coordination, operations, and literature research at organizations including Larvol LLC, Meril Lifesciences Pvt. Ltd., and Lambda Therapeutic Research Pvt. Ltd. I hold an MBA/PGDBM in Operation Management and a Bachelor of Pharmacy, and I’m willing to relocate and travel.

Experience

Work history, roles, and key accomplishments

Current

Quality Specialist (CAPA Writer)

Current

IQVIA RDS (India) Pvt. Ltd.

Aug 2025 - Present (1 year 1 month)

Lead investigations into deviations, non-compliance, and quality issues, performing root cause analysis and developing CAPAs. Maintain eQMS, ensure GxP compliance, and coach junior quality specialists.

CAPA Root Cause Analysis EQMS GxP ICH GCP ISO FDA EMA Quality Management Documentation Trend Analysis Coaching

Assistant Clinical Manager (Auditor)

COD Research Pvt. Ltd.

Apr 2023 - Jul 2025 (2 years 3 months)

Oversaw the Quality Management System, including SOPs, document control, change control, and ISO audits. Developed and executed audit plans, conducted investigator site, system, and vendor audits, and mentored junior QA auditors.

Quality Management Systems SOP Management Document Control Change Control ISO Auditing Audit Planning Investigator Site Audits Supplier Audits ICH GCP Risk Assessment Mentorship

Deputy Clinical Manager (Auditor)

Veeda Clinical Research Ltd.

Jan 2021 - Apr 2023 (2 years 3 months)

Conducted quality checks and performed system, site, vendor, alliance, and GxP audits. Managed audit planning, reporting, and CAPA closure, and facilitated sponsor audits and regulatory inspections.

Quality Assurance Audit GxP CAPA Change Control Deviation Management Trend Analysis Regulatory Inspections Software Validation

Analyst/Contractor

Larvol LLC

Jul 2020 - Jan 2021 (6 months)

Performed literature research for disease/therapeutic areas, searching patent and company websites to identify developments. Analyzed and summarized clinical trial information from registries and news sources.

literature review Clinical Trials PubMed Data Analysis Summarization

Clinical Research Associate

Meril Lifesciences Pvt. Ltd.

Feb 2020 - Jun 2020 (4 months)

Monitored clinical trials at sites, selected investigators, and liaised with doctors. Verified investigator training and protocol compliance, and coordinated clinical studies.

Clinical Monitoring Site management Investigation Selection Protocol Compliance Clinical Studies

Clinical Trial Assistant

Lambda Therapeutic Research Pvt. Ltd.

Mar 2018 - Feb 2020 (1 year 11 months)

Assisted clinical teams with documentation, site identification, and feasibility studies. Managed EC submissions and prepared site budgets and clinical trial agreements.

Clinical Documentation Site Identification feasibility studies EC Submissions Budgeting Clinical Trial Agreements

ETMF Specialist

Syntel Pvt. Ltd.

Feb 2017 - Feb 2018 (1 year)

Managed global trial master file quality for sponsor and CRO studies. Imported clinical documents into CREDI system and maintained study trackers.

TMF ETMF Credi Document Management Clinical Trials Data Imports

Project Coordinator

ClinAarc Pvt. Ltd.

Sep 2016 - Jan 2017 (4 months)

Executed clinical strategy at sites, overseeing patient recruitment and site support. Reviewed clinical data and provided training to site staff.

Clinical Operations Site management Patient Recruitment data review Training

Research Coordinator

Government Medical College and Hospital

Jan 2015 - Aug 2016 (1 year 7 months)

Coordinated daily clinical trial activities, ensured staff credentialing, and managed data collection and reporting. Participated in site visits and sponsor audits.

Clinical Trials Data Collection AE SAE Reporting Site visits Sponsor And Regulatory Audits