Sonal Negi
Senior Clinical Lead - Oncology Global Study Leadership @IQVIA
Signup · Get unlimited contacts
WORK HISTORY
Senior Clinical Lead - Oncology Global Study Leadership @IQVIA
CA
EDUCATION
Dr. M. G. R. Educational Research Institute (ICRI)
Master of Science - MS, Clinical Research
Guru Jambheshwar University
Master of Business Administration - MBA, Marketing
University of New Brunswick
Diploma in University Teaching, Education
The Association of Clinical Research Professionals
ACRP-CP® (Certified Professional), Clinical Research
Shardabai Pawar Women's College
Bachelor of Science - BS, Microbiology
Project Management Institute
Project Management Professional (PMP®), Project Management
University of New Brunswick
Master of Business Administration - MBA, Entrepreneurship and Technology Managament
ABOUT SONAL NEGI
I am Passionate with a brave mind; a seasoned Clinical research professional. I like to keep honing my skills in project management through active learning, esp. the soft skills (e.g. empathy, clear communication, etc.) which I believe differentiates a \"good\" and \"great\" project/ program manager. I graduated with an MBA and a Diploma in University Teaching from the University of New Brunswick, Canada in 2022. I am ACRP-CP® & PMP® certified, want to influence with impact. I am also an active volunteer in my community. In a career span of > 18 years, here are my contributions towards a healthier world- Recruitment Lead for a pre-exposure prophylaxis COVID19 study for immuno-compromised patients; 2550 subjects recruited across 120 sites in US & Canada in 7 months- Project Manager for a study on an anti-histamine drug for preventing Seasonal Allergic Rhinitis in 125 participants in Canada- Global Clinical Lead for a pediatric COVID19 vaccine study enrolling 14K subjects from APAC, LATAM and Africa - Regional Clinical Lead for APAC & EU for a dyslipidemia study which enrolled >12.5K patients from 32 countries in APAC, Latin and North Americas, Africa and EU- Global Clinical Lead for a Rheumatoid Arthritis study in 26 countries in APAC, EU, Latin and North Americas, and its extension study- Clinical Lead for an Oncology (Chronic Myeloid Leukemia) study in India- Global Project Manager for a Psychiatry (Major Depressive Disorder) study in India, US & Mexico- Clinical Project Manager for a Rotavirus (community based) & Rabies Vaccines (institutional) study in India- Monitoring in various studies in Endocrinology, Oncology, Cardio-vascular, Gastro-enterology, etc. Below are the activities I\'ve performed in my roles above- Managed all phases of the projects from Bid-defense to closure- Time/ Scope/ Finance/ Quality/ Risk/ Change Management on projects/ programs- Recruitment & retention of pediatric, adults and geriatric subjects- Investigator relationship management- Vendor selection & vendor management- Development of project tracking tools & study plans- Global SOP Author and Reviewer- Regional champion Risk-based Quality Monitoring- Audit & inspection preparation (DCGI, US-FDA)- Budget negotiation & contract finalization, Work orders & change orders- Training of investigator sites, budding clinical researchers, in-house employees & IRB/ IEC members
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.