Rohit Dubey
Clinical Data Strategist | Innovation Advocate | Ecosystem Builder | Exploring AI to Transform Clinical Trials
- Role
- Senior Principal Clinical Data Scientist at Novartis
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Rohit Dubey
With over a decade of experience in Clinical Data Management, I currently serve as Lead…
Experience
Senior Principal Clinical Data Scientist
Nov 2013 — Present · Hyderabad, IN
Leading priority studies under Cardio-Renal-Metabolic and Oncology therapeutic areas; consistently delivered quality milestones while managing ongoingtimelines. Led two priority RLT (Radioligand Therapy) prostate cancer trials as Program Manager during initiation phase; supported and stabilized a third struggling RLT program. Domain expertise in Respiratory therapeutic area; managed multiple studies and collaborated with trial data managers to ensuretimely, high-quality deliverables-Initiated and led Project ELEVATE, a capability-building initiative for ~40 DM professionals during its pilot phase. Conducted structured End-to-End DM training sessions with role-play exercises to build leadership and independent working skills-Managed end-to-end DM activities in a novel partnership model with an external organization; defined R&R, streamlined workflows, and conducted mockinspections for audit preparedness-Conceptualized and led the development of an AI-based DTS Module (in-house tool); reduced manual efforts by ~30% and improved quality by ~20%through automation. Pioneered the first BOT implementation in CDM for query management and report exports using RPA technology-Built UAT Assist – a test case bank and self-serve repository supported by a small team; optimized UAT processes across teams.
Education
S.P.C.P nagpur
B.pharm, Pharmacy
2005 — 2009
K.V. Vayusena Nagar, Nagpur
Higher secondary education, Science
1993 — 2005
Nagpur University
Bachelor of Pharmacy - BPharm, Pharmacy
United business institutes
Master of Business Administration (MBA), Project Management
2012 — 2013
Skills
- Sas
- Data Management
- Cdm
- Pharmaceuticals
- Clinical Reasearch
- Clinical Development
- Gcp
- Clinical Data Management
- Clinical Research
- Oracle Clinical
- Clinical Trials
- Pharmaceutical Industry
- Sop
- Research
- Clinical
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