Pankaj Kumari

Oracle Clinical/Remote Data Capture, Inform, Medidata Rave, Zelta Trials, Datatrak, Datstat, Greenlight Guru, Smarttrial, MS Project, Smartsheet, Spotfire, Qliksense, Azure Dev Ops

• Working with other cross functional teams such as Regulatory, Clinical development, Clinical Operation, CDM, Statistics and Medical Writing.
• Led multiple global drug and medical device trials in various therapeutic areas such as Oncology, Cardiovascular, Musculoskeletal, Ophthalmology, Women's Health, Oral Healthcare, Image Guided Therapy etc..
• Work closely with customers to understand value proposition, business requirements, feature enhancement and developing roadmap with Clinical development team and different markets for product development.
• Perform root cause analysis to provide long-term prevention of device defects and provide input for CAPA., Vendor management inclusive of review of SLA and metrics and contracts.
• Leading OQ/PQ testing including verification, validation & documentation plans., Managing diverse teams locally and globally.
• Recruit, train/mentor new hires.
• Resource allocation and time management.
• Conflict resolution and negotiation.
• Performance Assessment and objective appraisal discussion.
• Medidata deployment including EDC, CTMS, RSR, Imaging, RTSM with validation.
• Validation of eDC, eConsent, ePRO tools.
• Device Regulatory Reporting Requirements (FDA Combination Product/ EUMDR etc.).
• Process re-engineering and process improvement initiative using LEAN, Agile etc.