Vinaykumar Nandimath
@vinaykumarnandimath
Director of Clinical Operations with 23+ years leading global Phase I–IV trials and teams.
IndiaWhat I'm looking for
I’m a Strategic Clinical Research leader with 23+ years of experience delivering optimal results in global clinical operations. I specialize in oversight of complex, multi-regional Phase I–IV studies across South Asia, Asia Pacific, and global markets, spanning Biosimilars, Vaccines, Oncology, Psychiatry, Neurology, and Cardiovascular medicine.
I’ve built and scaled clinical operations functions, leading regional teams across India, South Asia, South Africa, China, Taiwan, the Philippines, and Malaysia. I also provide clinical trial consulting—advising multi-speciality hospitals on GCP compliance, regulatory alignment, clinical research budgeting, SOP creation, and process optimization for efficient study execution.
My leadership style blends strategic decision-making with hands-on governance. I’ve managed cross-functional teams (PMs, COLs, CTLs, LSMs, CRAs, CTAs), delivered training frameworks, and driven inspection readiness through risk identification, gap assessments, and quality-driven initiatives. I’m also experienced in vendor selection and CRO governance, including contract alignment, budget oversight, issue escalation, and audit-readiness.
In my current and recent roles, I’ve owned country strategy and operational plans, including feasibility, site selection, start-up, conduct, and closure deliverables—while ensuring high-quality and scientific integrity. I’ve also led global clinical monitoring, championing risk-based and remote monitoring approaches, modern oversight models, and continuous performance analytics to strengthen data quality and reduce protocol deviations.
Experience
Work history, roles, and key accomplishments
Led country-level clinical development operations for India, covering feasibility, site selection/start-up, study conduct/closure, and country CDO deliverables. Owned inspection readiness, resource planning and hiring, and country budget planning/forecasting.
Provided strategic and operational leadership for global clinical monitoring across biologics programs, ensuring compliance, data integrity, and high-quality trial execution. Managed CRO/vendor identification and selection, line-managed global monitoring teams, and implemented risk-based/centralized and digital monitoring approaches.
Oversight Director, Global Projects
Feb 2022 - Dec 2022 (10 months)
Provided end-to-end oversight for global clinical development programs, ensuring delivery against scope, timeline, budget, and quality. Led cross-functional teams, managed financial governance and risk mitigation, and oversaw vendor/CRO governance.
Consultant - Clinical Research Operations
Multi-Speciality Hospitals (Independent Consultant)
Jun 2021 - Jan 2022 (7 months)
Consulted with multi-speciality hospitals on establishing and scaling clinical research infrastructure aligned with GCP and regulatory requirements. Led clinical team setup and SOP development, provided budgeting guidance, and supported ongoing compliance and documentation practices.
General Manager, Clinical Ops - SouthAsia
May 2012 - May 2021 (9 years)
Built and led South Asia clinical operations, providing regional accountability for clinical trial delivery, budgets, and people management across South Asia. Oversaw CRO selection and clinical systems implementation, including investigator payments and fair market value standardization.
Clinical Project Manager/Team Leader
Nov 2006 - May 2012 (5 years 6 months)
Led global and regional clinical trials across Asia Pacific, driving on-time delivery and compliance for Phase II–IV studies. Managed quality and risk mitigation, developed monitoring strategies, and supported client satisfaction through strong execution and cross-functional collaboration.
Senior Clinical Research Associate
Aug 2005 - Nov 2006 (1 year 3 months)
Executed end-to-end clinical site responsibilities, including monitoring, regulatory submissions, and close-outs across multiple therapeutic areas. Supported audit readiness and data integrity through SAE tracking, IP accountability, and site engagement.
Clinical Research Associate
Feb 2004 - Aug 2005 (1 year 6 months)
Handled clinical site responsibilities across therapeutic areas, including site monitoring, documentation, and close-out activities. Contributed to global project meetings and supported alignment with sponsor expectations.
Scientific Officer
Serdia Pharmaceuticals (India) Pvt Ltd
Sep 2000 - Jan 2004 (3 years 4 months)
Conducted post-marketing clinical trials and CME programs to support scientific visibility and product credibility. Led scientific engagement initiatives and supported field team training and mentoring.
Sales Representative
Elder Pharmaceuticals Ltd.
Apr 2000 - Aug 2000 (4 months)
Worked in pharmaceutical sales and marketing, supporting stakeholder engagement and facilitating collaboration between commercial and clinical teams. Applied sales experience to inform trial and site engagement perspectives.
Education
Degrees, certifications, and relevant coursework
K. L. E’s College of Pharmacy
Bachelor of Pharmacy, Pharmacy
Earned a Bachelor of Pharmacy from K. L. E’s College of Pharmacy in Hubli, affiliated with Karnataka University.
Availability
Location
IndiaAuthorized to work in
Job categories
Skills
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