Greater Delhi Area
Clinical research leader with expertise in project management, strategic planning and implementation, vendor management, team management, compliance and quality management for Asian countries. Over 18 years of experience in global clinical studies (Pre-market, Post-market, IDE, PMS & RWE ) on medical devices & drugs. Domain expert in Clinical operation, project management, medical writing, regulatory writing, bio-availability and bio-equivalence studies.
Responsible for Clinical Operations for Medical Device Division for India, South Korea and South East Asia.
Managment of Clinical Projects for India, HK, Taiwan and South East Asia
Overall responsible for Clinical Affairs operations for India,SE Asia, Hong Kong and Taiwan.
In-charge of clinical team operations for India. Clinical Project Management (pre-market local and post market global clinical studies) in India. Project Manager for specific global clinical projects for Asia (Singapore, India, Hong Kong, China, South Korea) & Japan.
Clinical project leader for India sites for global St. Jude Medical studies. Clinical study dossier review for regulatory submissions for India.
Clinical study operations and management, Site monitoring and documentation. Clinical study document review and preparation (study protocols, case report forms, investigator’s brochures, clinical study reports, clinical manuscripts and abstract submissions) & coordination with cross functional teams for finalization for different phases of drug development for India marketing authorizations.
Clinical trial monitor, medical writer (clinical and regulatory) for clinical trials in India and bio-equivalence study designing for EMEA region, Australia, Canada & Russia.
Data collection and analysis