Raxit Patel
@raxitpatel
Senior clinical research contract and project leader delivering compliant trials across Phases II–IV and BA/BE.
IndiaWhat I'm looking for
I’m a clinical research professional with 12.5+ years of success in end-to-end clinical trial management across Phases II–IV and BA/BE studies. My focus is delivering compliant, on-time execution through strong site start-up, project, and vendor management.
In my current role as Sr. Site Contract Manager (IQVIA RDS (India) Pvt. Ltd. (FSP)), I develop investigator grants, contract strategies, and payment templates. I also manage contract language and systems such as CTMS, align on timelines, and track financials while collaborating with global stakeholders to support compliant delivery.
Previously, as an Associate Clinical Project Manager, I led regional study delivery and milestone achievement. I built study management plans, drove protocol compliance, handled risk and scope changes, and oversaw vendor performance—while mentoring junior team members and representing projects in client discussions.
Earlier experience at JSS Medical Research strengthened my operational foundation: selecting and initiating sites, negotiating contracts and budgets, monitoring enrollment and regulatory compliance, and supporting CRA/APM performance and audits. I’ve also supported start-up meetings, site audits, FDA inspection readiness, and TMF/eTMF documentation—grounded in ICH-GCP, US FDA, DCGI expectations, and global SOPs.
Experience
Work history, roles, and key accomplishments
Develop investigator grants, contract strategies, and payment templates, and manage contract language, CTMS, timelines, and financial tracking. Collaborate with global stakeholders to support compliant, on-time delivery.
Led regional study delivery and milestone achievement by developing study management plans and ensuring protocol compliance. Managed risk and scope changes, oversaw vendors, and supported financial success.
Project Manager
JSS Medical Research Asia Pacific Pvt. Ltd.
Sep 2021 - Sep 2022 (1 year)
Selected and initiated clinical trial sites and handled negotiation of contracts and budgets. Monitored enrollment, site progress, and regulatory compliance, and oversaw CRA/APM performance, vendor coordination, and audits.
Assistant Project Manager
JSS Medical Research India Pvt. Ltd.
Jan 2021 - Aug 2021 (7 months)
Facilitated start-up meetings and site audits, supporting FDA inspection readiness. Supervised CRAs, tracked retention/enrollment, and managed eTMF documentation.
Sr. Clinical Research Associate
JSS Medical Research India Pvt. Ltd.
Apr 2020 - Dec 2020 (8 months)
Managed site TMFs, trained staff, and conducted remote and on-site site visits. Ensured adherence to SOPs, ICH-GCP, and regulatory frameworks.
Clinical Research Associate
JSS Medical Research India Pvt. Ltd.
Mar 2018 - Mar 2020 (2 years)
Oversaw trial operations with vendor collaboration and ensured compliance. Contributed to recruitment strategies and investigator engagement.
Clinical Research Coordinator
Various Organizations
Jan 2013 - Mar 2017 (4 years 2 months)
Performed site qualification and subject screening, and supported ICF, SAE reporting, and TMF maintenance. Coordinated communication with ethics committees, vendors, and study sponsors.
Education
Degrees, certifications, and relevant coursework
Everest University
Master of Business Administration, International Business
Completed an MBA in International Business at Everest University in 2010.
North Maharashtra University
Bachelor of Pharmacy, Pharmacy
Earned a Bachelor’s degree in Pharmacy from North Maharashtra University in 2005.
Availability
Location
IndiaAuthorized to work in
Job categories
Skills
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