Full Description

Are you a detail‑driven QA expert who's passionate about upholding exceptional GCP standards, driving quality improvements, and shaping the future of oncology clinical trials? Proclinical is seeking an Associate Director of Clinical Quality Assurance to support clinical programs and trials with a focus on Good Clinical Practice (GCP) compliance. This role involves ensuring the highest quality standards in clinical trial documentation, managing quality issues, and preparing for regulatory inspections. If you are passionate about driving quality improvements in oncology treatments, this opportunity is for you. This is a remote working position which can be based across Europe or United States.

Responsibilities

• Review key clinical trial documentation, including protocols, investigator brochures, informed consent forms, and trial master files.
• Lead assessments and investigations of quality issues, including root cause analysis, remediation, and timely resolution.
• Facilitate reviews of potential serious breaches and urgent safety measures for assigned clinical programs.
• Coordinate GCP-GVP vendor audits, manage audit programs, and ensure proper execution and closure of audits.
• Oversee quality management with functional lines and vendors, including leading Quality Oversight Committee meetings.
• Collaborate on implementing risk-based quality management (RBQM) strategies for studies, including critical data identification and reporting.
• Lead pre-approval and routine regulatory inspection readiness activities, including risk analysis and strategy development.
• Provide guidance and training on compliance issues, leveraging expertise in GCP and industry best practices.
• Support the development, implementation, and maintenance of GCP standard operating procedures (SOPs).

Key Skills and Requirements

• Strong background in clinical quality assurance and GCP compliance.
• Experience in reviewing and managing clinical trial documentation.
• Knowledge of regulatory inspection processes and risk-based quality management.
• Ability to lead audits and manage CAPAs effectively.
• Familiarity with oncology clinical trials is preferred.
• Excellent problem-solving skills and adaptability.
• Strong communication and collaboration abilities.
• If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com.
• If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.