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