Clinical Trials - Quality Assurance

Key Responsibilities: To perform the role as Clinical Trials - QA auditor to verify compliance with respect to ICH-GCP, applicable regulatory requirements and Study Protocol for Clinical site, Pharmacy, Biometrics, clinical data management and Medical writing activities for patient based (Phase I, II, III and IV) studies. GCP clinical Trial QA auditor with 6-9 years of experience in performing Clinical trials investigational sites GCP QA audits across India and other international destinations. Collate data for clinical quality metrics and report. Perform system and study audits with respect to Pharmacy, Biometrics, clinical data management and Medical writing functions. Perform vendor audits based upon quality risk assessment. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety Attend training on environment, health, and safety (EHS) measures imparted company.