Samiran Maity

Clinical Quality Assurance (QA) & Clinical Competency Development. Key responsibilities are like below 1. Plan & execute clinical QA activities like internal GCP audit (CQSV) at investigational site, local trial management, local vendor, critical clinical process etc. 2. Handled all local and global regulatory inspection (Pre-During-Post Phase) 3. Plan & execute several quality management system (QMS) related critical activities including QMR, SOP/GCP support, serious breach evaluation etc.

1. Global Project Management for multiple therapy areas (From feasibility till project closure). Smart recruitment and retention strategy for challenging protocols. New site development 2. Line/People Management for a team of ~10 (CTA, CRA, CTL). 3. Operational Quality Management via real time Audit/Inspection readiness 4. New Clinical Process Management to comply with internal and external requirements like process for Audio Video Consenting, EMR handling, Handover process development etc.

INDIA - Managed multicenter, global clinical trial (phase 2, 3, 4) which includes recruitment, retention, site monitoring, site management & trial management, audit/inspection readiness. EGYPT- Qualified Egypt to start new multinational clinical trial via establishing required infrastructure and capacity buildings which includes but not limited to country level feasibility, site selection, local team and process development, run pilot interventional trial, passing GCP audit etc.

Promote anti diabetic (oral and Insulin) brands in highly complex and competitive market

1. Clinical Research 2. ICH-GCP 3. Global Regulatory Requirements

1. Pharmaceutics 2. Pharmacology 3. Pharmaceutical Chemistry 4. Medicinal Chemistry