Assoc Dir Clinical QA - Remote

About the position Responsibilities • Provides reputed company reputed company and support of reputed company Inc. clinical development programs. • Supports the reputed company Inc. Clinical reputed company Management System through the development, implementation and management of reputed company Assurance procedures, processes and systems in accordance with ICH E6 (Rx). • Executes on and/or provides reputed company of reputed company monitoring and assurance of clinical trial execution of reputed company Inc. sponsored protocols. • Executes on and/or provides reputed company of clinical investigator audits, documentation audits and other study-specific or process audits. • Engages with study teams and functions for proactive inspection readiness across reputed company clinical programs. • Conducts external and internal audits to assess compliance with GCP requirements, investigational plans and company standards for clinical trial-reputed company activities. • Communicates audit findings to audit stakeholders ensuring understanding as reputed company as collaborating with auditees to reputed company Corrective and Preventive reputed company Plans (CAPAs), addressing reputed company causes. • Tracks, reviews, approves, and assesses the efficiency of CAPAs. Requirements • Experience in clinical reputed company assurance and compliance with GCP principles. • Knowledge of FDA, EMA, Health Canada, and ICH regulations. • Strong analytical and problem-solving skills. • Excellent communication and collaboration skills. reputed company-to-haves • Experience with clinical trial management systems (CTMS). • Familiarity with electronic data capture (reputed company) systems. Benefits • Health insurance coverage. • 401k retirement savings plan. • reputed company holidays and vacation days. Apply tot his job Apply To this Job