Mundra Hanumantharao
Pharma IT solution lead| Clinical, Medical, Safety & Regulatory technology solutions expert| R&D Life sciences| M&A| Clinical Data Management| CTMS, eTMF, CDMS, IRT, IRMS, Argus, Medcomms, CRM, D2, RIMS, LIMS, trackwise.
- Role
- Global Digital R & d & Clinical Platforms Lead at Sanofi
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Mundra Hanumantharao
Global Clinical and Medical IT Business Technology Management - Accountable for…
Experience
Global Digital R & d & Clinical Platforms Lead
Jul 2024 — Present · Hyderabad, IN
Strategic Technology Liaison: Act as the central link between the Global Science - Research & Development and Clinical functions and technology providers, overseeing the delivery of digital solutions for R&D information. Establish and maintain strategic vendor relationships and governance structures.Digital Strategy: Develop and execute a comprehensive digital strategy for Research & Development and Clinical functions platforms, aligning with organizational goals and regulatory requirements.Technical Solutions Leadership: Lead discussions on technical feasibility, prototype development, and the design of efficient, adaptable, and scalable technology solutions, all in adherence to company policies, regulatory standards, and integration goals.Technology Roadmap Execution: Manage the execution of the approved technology roadmap, ensuring the delivery of development and validation artifacts to meet high-quality standards, compliance, and audit readiness.Team Leadership: Build, mentor, and lead a high-performing team of digital experts (both internal & external) focused on R&D and Clinical domains, fostering innovation and excellence.Regulatory Compliance: Ensure that relevant digital platforms and processes comply with all relevant regulatory requirements, maintaining the highest standards of quality and safety. Financial Planning and Governance: Contribute to the annual digital investment, budgeting, and planning processes. Manage project budget requirements and actively participate in digital and R&D governance forums.Platform Compliance: Collaborate closely with relevant stakeholders to ensure that solutions are developed in accordance with the requirements of 21 CFR Part 11 and systems validation standards, ensuring regulatory compliance and data integrity.
Education
Suresh Gyan Vihar University
Master of Business Administration - MBA, Information Technology
Skills
- Clinical Data Management
- Oracle Clinical
- Product Launch
- Pharmacovigilance
- Capa
- Pharmaceutical Industry
- Gcp
- Clinical Trials
- Ich-Gcp
- Edc
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