Himanshu Manika Shah
Regional Director - APAC, Labs Relationship Management, Global Clinical Trial Operations, MSD
- Role
- Regional Director - Apac (Labs Relationship Management, Hq Ops) at MSD
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
About Himanshu Manika Shah
Diverse Clinical Research experience across - Phases Phase (including First In Man)- Industry (CROs and pharmaceuticals)- Site Monitoring, Project management, Outsourcing, Medical writing, CRF Designing, Supply Chain, Legal- Pharmacovigilance, training, financial forecasting & management, Licensing- Outsourcing, Contracts/Budgets Management, Vendor qualification & relationship management- Direct experience across Asia Pacific countries, exposure to EEMEA & Latin America- Experience working with CROs and for CROs - Computer system validation and lifecycle, Clinical IT applications implementation & training, Conceptualization & /or implementation of multiple Pharma IT applications - L&D (TNA, LSA, CADDIE, LMS, Metrics, ILT/VILT/eLearning, Curricula Implementation, Social learning, Learning technologies)Specialties- Phase I,II, Clinical trials- Sourcing, Procurement- IT in clinical trials- Virtual Learning
Experience
Regional Director - Apac (Labs Relationship Management, Hq Ops)
Jan 2024 — Present
Education
UCLA Anderson School of Management
Post Graduate Program in Management, Business Management
2018 — 2019
Gujarat University
Bachelors of Pharmacy, Pharmacy
1996 — 2000
BII
Industrial Diploma in Clinical Research & Contract Research, clinical research, contract research
2005 — 2005
Skills
- Phase I
- Learning & Development
- Clinical Trials
- Pharmacovigilance
- Ich-Gcp
- Computer System Validation
- Oncology
- Pharmaceutical Industry
- Clinical Development
- Outsourcing
- Innovation
- Clinical Monitoring
- Clinical Data Management
- Virtual Learning
- Clinical Research
- Medical Writing
- Edc
- Ctms
- Clinical Operations
- Gcp
- CRO
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