Assoc Dir Clinical QA - Remote
About the position
- Responsibilities
- Provides Quality oversight and support of Tolmar Inc. clinical development programs.
- Supports the Tolmar Inc. Clinical Quality Management System through the development, implementation and management of Quality Assurance procedures, processes and systems in accordance with ICH E6 (Rx).
- Executes on and/or provides oversight of quality monitoring and assurance of clinical trial execution of Tolmar Inc. sponsored protocols.
- Executes on and/or provides oversight of clinical investigator audits, documentation audits and other study-specific or process audits.
- Engages with study teams and functions for proactive inspection readiness across all clinical programs.
- Conducts external and internal audits to assess compliance with GCP requirements, investigational plans and company standards for clinical trial-related activities.
- Communicates audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to develop Corrective and Preventive Action Plans (CAPAs), addressing root causes.
- Tracks, reviews, approves, and assesses the efficiency of CAPAs.
- Requirements
- Experience in clinical quality 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.
- Nice-to-haves
- Experience with clinical trial management systems (CTMS).
- Familiarity with electronic data capture (EDC) systems.
- Benefits
- Health insurance coverage.
- 401k retirement savings plan.
- Paid holidays and vacation days.
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