Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Publication & Presentations
Timeline
Generic

SANDIP PATIL

Medical Governance & Local Study Manager
Mumbai

Summary

  • Clinical Research Professional with 13+ years of comprehensive experience in managing global interventional, local NIS & RC studies from start-up to closure ensuring strict adherence to regulatory requirements, timelines, and budgets.
  • Proven leadership in managing and mentoring clinical associates to drive successful execution of clinical trials and MAP/PSDS programs.
  • Actively contributed as a Global Process Contributor and Subject Matter Expert (SME) in SOP revisions, playing a pivotal role in regional and global initiatives within the Medical Governance community.
  • A trusted advisor in medical governance, providing expert guidance, coaching, for evidence generation activities and oversight for regulated activities.
  • Excellent in stakeholder engagement, regulatory coordination, trial budgeting, and known for a collaborative mindset, operational excellence, and a commitment to continuous improvement in clinical research practices.

Overview

13
13
years of professional experience
2
2
Certifications

Work History

Medical Governance & Local Study Manager

Novartis Healthcare Private Limited
07.2015 - Current
  • Progressively advanced within Novartis from CRA to Sr CRA, Assistant Manager, Local Study Manager & now Medical Governance & Local Study Manager demonstrating a strong track record of performance, leadership, and increasing strategic responsibility in clinical operations & Medical Governance.
  • Managing operational aspects of multiple LIS, NIS & RCs from study start-up through study closure in adherence to Novartis & regulatory requirements, timelines, and budgets.
  • Leading and managing the clinical associate, providing strategic direction and oversight of day-to-day clinical operations across the studies & MAP/PSDS Programs.
  • Developing and maintaining project timelines and budgets resulting in on-time study completion within budget.
  • Third-Party Management and monitoring by performing Due Diligence Assessment of Collaborating Partner by ensuring completion of TPIAT & EPRM.
  • Supporting in development of Concept Sheet, Protocol, ICF & CRF, CSR/TPSR & also facilitating for medical and scientific review /MASRC of concept sheet.
  • Acting as the local lead for 5 MAPs & 8 PSDS Program and key link between the global and local Medical Affairs teams, ensuring strategic planning and early access strategy for the product in the country.
  • Leading Local Medical Governance Committee (LMAC) to ensure effective oversight, risk management and timely decision making on Medical Affairs owned activities (evidence generation activities).
  • As Medical Governance Manager, led governance of regulated activities (LIS, NIS/RWE, MAP, PSDS RC), contributing to strong compliance and resulting in only minor observations during recent CDA and PV audits.
  • Monitoring and reporting KPI/KQI using Local & Global systems/tools.
  • Served as the operational lead for global studies, providing strategic support to the Study Manager to ensure timely achievement of key project milestones.
  • Provided mentorship to CRAs, strengthening their process knowledge and system proficiency to improve overall monitoring effectiveness and team capability.
  • Demonstrated advanced proficiency in systems like Site Cockpit, leading to recognition as the country-level champion and super user.

Clinical Research Associate

Bharat Serums & Vaccines Limited
05.2013 - 07.2015
  • Monitored and managed clinical trial sites to ensure compliance with study protocols and regulatory requirements.
  • Conducted site feasibilities, initiation, monitoring, and close-out visits resulting in successful study completion.
  • Reviewed and verified study data and source documents resulting in high-quality data for analysis.
  • Managed assigned study sites according to the monitoring plan and Novartis procedures.
  • Negotiated investigator for remuneration, prepared financial Clinical Trial contracts.
  • Administered protocol and related study training to CRCs and establish regular lines of communication with sites to manage ongoing project expectations and issues.

Clinical Research Coordinator

LTM Medical College & Hospital
02.2012 - 05.2013
  • Managed and coordinated more than 5 clinical trials in alignment with study protocols, GCP, and regulatory requirements.
  • Achieved patient enrollment targets as per initial site commitment, contributing to overall study timelines and deliverables.
  • Led site preparation for initiation, monitoring, close-out, audits, and inspections to ensure readiness and compliance.
  • Communicated protocol requirements effectively across the study team, ensuring consistent adherence to guidelines.
  • Reported safety data in accordance with sponsor, regulatory, and local reporting requirements.
  • Maintained study documentation and data integrity in compliance with ethics committee (EC), sponsor, and regulatory standards.

Education

Master of Pharmaceutical Medicine - Clinical Drug Development

Maharashtra University of Health Science
Mumbai, India
04.2001 -

Bachelor of Pharmacy - Pharmaceutical Sciences

North Maharashtra University
Jalgaon, India
04.2001 -

Skills

  • Clinical Project Management
  • People Management
  • Third Party Management
  • Budgeting & Financial Reconciliation
  • Trial Systems & Processes
  • Risk Management
  • Cross functional Collaboration
  • Strategic Problem Solving

Accomplishments

  • Operational Excellence Awards 2022-2023-2024
  • Galaxy Team Award 2022 & 2024
  • Patient Access Award 2024
  • Selected as Responsible pillar of HERO movement at CPO
  • HATS-OFF Awards

Certification

ICH-GCP

Publication & Presentations

  • Poster Presentations 2
  • Publication in Scientific Journal 1

Timeline

Medical Governance & Local Study Manager

Novartis Healthcare Private Limited
07.2015 - Current

Clinical Research Associate

Bharat Serums & Vaccines Limited
05.2013 - 07.2015

Clinical Research Coordinator

LTM Medical College & Hospital
02.2012 - 05.2013

Master of Pharmaceutical Medicine - Clinical Drug Development

Maharashtra University of Health Science
04.2001 -

Bachelor of Pharmacy - Pharmaceutical Sciences

North Maharashtra University
04.2001 -

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SANDIP PATILMedical Governance & Local Study Manager