Preethi Sharon
@preethisharon
Senior Study Start-up Specialist driving compliant clinical trial start-ups across India with strong regulatory and TMF expertise.
IndiaWhat I'm looking for
I’m a Senior Study Start-up Specialist with a strong clinical research foundation from my Doctor of Pharmacy training and hands-on experience supporting clinical trials from start-up through closure. My focus is ensuring trial start-up activities are executed with quality, clear documentation, and timely deliverables.
At Novo Nordisk India, I’ve progressed from Clinical Trial Administrator to Study Start-up Specialist, and now to Senior Study Start-up Specialist, where I provide oversight across start-up responsibilities, lead process development and streamlining, and act as the primary liaison for India systems and processes. I manage country/site-specific deliverables such as ICF customization and verification, agreement/amendment preparation and execution, HA/EC dossier support, eTMF/TMF QC, GLF readiness, and site activation planning—while also mentoring interns and junior colleagues; I was awarded Best Study Start-up Specialist consecutively for 2024 and 2025 and contributed to process innovation and training for the wider team.
Experience
Work history, roles, and key accomplishments
Provides oversight across start-up activities, leads process development and streamlining, serves as a liaison to the global team on India start-up systems and processes, and mentors interns and junior colleagues.
Owned study start-up execution for India, including site readiness activities, document preparation and approvals, eTMF maintenance, regulatory submissions support, and updates to clinical trial registries.
Managed clinical trial documentation and submission activities, including preparing agreements and amendments, handling informed consent materials, and supporting Health Authority and Ethics Committee dossiers.
Supported clinical trial start-up, execution, and closure activities by partnering with Clinical Trial Administrators, Project Managers, and Clinical Research Associates to deliver required project deliverables.
Clinical Pharmacist Intern
KIMS Hospital and Research Centre
12-month internship as a Clinical Pharmacist at KIMS Hospital and Research Centre.
Education
Degrees, certifications, and relevant coursework
Visveswarapura Institute of Pharmaceutical Sciences
Doctor of Pharmacy (Pharm D), Pharmacy
2015 - 2021
Completed Pharm D (Doctor of Pharmacy) at Visveswarapura Institute of Pharmaceutical Sciences, affiliated with Rajiv Gandhi University of Health Sciences (RGUHS), Bangalore, from 2015 to 2021.
MES College, Bangalore
Pre-University Education
2013 - 2015
Completed pre-university education at MES College, Bangalore, affiliated with the Karnataka Board, from 2013 to 2015.
Mother Teresa High School, Bangalore
SSLC
2013 -
Completed SSLC at Mother Teresa High School, Bangalore in 2013 (Karnataka State Secondary Education Examination Board).
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Job categories
Skills
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