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Jayash Kale
Clinical Project Manager
Clinical Project Manager
Jayash Kale is a Clinical Project Manager with 8+ years of experience in global clinical operations, study start-up, data oversight, and vendor management across oncology and consumer health trials. Skilled in full study lifecycle management, regulatory compliance (ICH-GCP, FDA), and stakeholder coordination, he leads cross-functional teams to ensure timelines, quality, and inspection-readiness. Proficient in Medidata Rave, Veeva Vault, Oracle Clinical, and RedCap.
FORMERLY AT
Kenvue
LOCATION
Mumbai, India
AVAILABILITY
Full-time
Skills
Clinical Documentation
Data Validation & Reconciliation
EPIC EHR
IBM Inform
Medical Charting
Medidata Rave
Oracle Clinical
Project & Site Management
REDCap
Risk & Budget Management
Veeva Vault
Vendor/CRO Oversight
Work Experience
Senior Clinical Research Associate – Oncology Trials
Vasta Global Pvt. Ltd.
January 2018 – August 2023
- Led clinical data operations for 20+ oncology trials (breast, ovarian, pediatric neuroblastoma).
- Performed discrepancy management, data validation, EDC reconciliation, and audit readiness.
- Supported CRF design, database submissions, and mentored junior CRA team members on EDC/data workflows.
TECHNOLOGIES
Medidata Rave, Oracle Clinical, RedCap, IBM Inform, Data Validation & Reconciliation
Clinical Associate – Virtual Medical Scribe
IKS Health
August 2017 – January 2018
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Documented real-time physician consultations for Massachusetts General Physicians Organization in EPIC EHR, improving documentation accuracy and clinical workflow efficiency.
TECHNOLOGIES
EPIC EHR, Clinical Documentation, Medical Charting
