Open To Work
Rohit Dubey
Hyderabad,TG
Summary
Dynamic Lead Principal Clinical Data Scientist at Novartis Healthcare, recognized for implementing innovative AI solutions that enhance operational processes. Proven ability in clinical data management and effective team leadership, ensuring quality and compliance in deliverables. Strong focus on stakeholder engagement and nurturing talent to create high-performing teams.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Lead Principal Clinical Data Scientist
Novartis healthcare Limited
Hyderabad
11.2013 - Current
- Leading Top priority studies within the Biomedical Research group, previously delivered milestones on Cardio-Renal-Metabolic and Oncology therapeutic areas with consistency and quality.
- Successfully managed two Radioligand Therapy (RLT) prostate cancer trials as Program Manager during the initiation phase. Domain expertise in the Respiratory therapeutic area
- Team Management, coaching, defining development plans, succession planning, Resource management, monitoring functional performances, building culture aligned with Org Commitment. Built system for success to bring efficiency in work beyond processes.
- Initiated and led Project ELEVATE, a capability-building pilot for ~40 DMs, designing and delivering structured end-to-end DM Mentorship with role-play exercises to enhance leadership, autonomy, and cross-functional readiness.
- Conceptualized and spearheaded development of an AI-driven DTS Module (DOA), automating manual processes to enhance data quality and operational efficiency.
- Handled several Audits and Inspections, associated CAPAs and closures.
- Pioneered Project EAGLE, a standardization effort for End-to-End Data management Respiratory TA achieved 92% alignment.
- Represented Novartis DM in a novel external partnership model. Defined RnR, streamlined workflows, and conducted mock inspections to ensure audit readiness and operational excellence.
- Built UAT Assist, a test case bank and self-serve repository to optimize UAT effort across teams, improving scalability and reducing turnaround time.
Data Manager
Cognizant Technology Solutions
Mumbai
10.2012 - 10.2013
- Managed data for 3 major studies/registries in Lysosomal Storage Disorders (LSD) under the Genetic Disorders therapeutic area.
- Reviewed eCRFs daily per Data Review Guidelines; performed self-evident corrections and closed discrepancies.
- Conducted duplicate data reconciliation and external manual checks for data consistency.
Process Associate-CDM
Tata Consultancy Services
Mumbai
05.2011 - 09.2012
- Supported 2 Phase III Cardiovascular studies with full-scope clinical data management responsibilities.
- Reviewed 3 protocols and adhered to client-specific quality standards and timelines.
- Identified and resolved data discrepancies; coordinated with Client's Lead DM for escalations.
- Participated in regular client meetings for trial updates and data issue resolution.
Sales Officer
Sun Pharmaceutical
Pune
09.2010 - 03.2011
- Promoted Sun Pharma's neurology product portfolio to general physicians, neurologists, and psychiatrists across Pune territory.
- Achieved 120% of monthly targets for key neuro brands.
- Developed and executed sales strategies to increase market penetration and revenue growth.
Production Pharmacist
Emcure Pharmaceutical
Pune
01.2010 - 07.2010
- Operated and monitored granulation equipment such as Rapid Mixer Granulator (RMG), Fluid Bed Dryer (FBD), Multi Mill, and Sifter under GMP conditions.
- Executed wet and dry granulation processes as per batch manufacturing records (BMRs) and Standard Operating Procedures (SOPs).
Education
International MBA - Project Management
United Business Institutes (UBI)
Brussels, Belgium09-2013
B. Pharmacy - Pharmacy
Nagpur College of Pharmacy, Nagpur University
Nagpur05-2009
Skills
- End to End Clinical Data Management
- Audit and compliance
- Data Governance
- Project Management
- Team Leadership
- Talent Development - Capability building
- Resource optimization
- Stakeholder engagement
- Strategic thinking
- Process automation and innovation
- Basic Python coding
- GenAI prompt engineering-AI Agents (MS365 Copilot, ChatGPT)
Certification
- Google Project Management Professional Certification, Google LLC
- MS365 GenAI Certificate, Microsoft
- Base SAS Certification, SAS Institute
- Visionary leadership, identity & motivation: Become a meaning maker
Additional Information
- StudyBuddy- A protocol Simplifier AI Agent, explains Protocol in simplest way possible, Conversational in nature
- SMEBot- An AI agent under development to act as a preliminary SME , trained on SME portal data and the Process and reference guides. Conversational in nature.
- DataCian- Copilot agent designed as a Data physician to diagnose issues in data, detect anomalies and suggest possible hidden insights.
- CheckMate- A Copilot agent designed to generate check-in MS copilot combing through the content and have quality conversation with managers.
- System for Success- A list of must haves within a team to ensure Compliance comes naturally as an outcome.
- ELEVATE- Capability build project within DM circle
- Personal project: Revamped the business model for a QSR, utilizing AI Prompt engineering skills to generate leads, establish processes, remove redundancies and create ideas for brand recognition. This increased customer engagement by 30% and enhanced operational efficiency.
Languages
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Marathi
Upper intermediate (B2)
Telugu
Elementary (A2)
Timeline
Lead Principal Clinical Data Scientist
Novartis healthcare Limited
11.2013 - Current
Data Manager
Cognizant Technology Solutions
10.2012 - 10.2013
Process Associate-CDM
Tata Consultancy Services
05.2011 - 09.2012
Sales Officer
Sun Pharmaceutical
09.2010 - 03.2011
Production Pharmacist
Emcure Pharmaceutical
01.2010 - 07.2010
International MBA - Project Management
United Business Institutes (UBI)
B. Pharmacy - Pharmacy
Nagpur College of Pharmacy, Nagpur University