Are you driven by improving oncology outcomes and looking for a role where quality truly matters? Looking for a flexible position where you can work from the comfort of your home?
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, addressing quality issues, and preparing for regulatory inspections.
Responsibilities:
- Review key clinical trial documentation, including protocols, investigator brochures, informed consent forms, and trial master files.
- Lead assessments and investigations of quality issues, driving 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) for studies, focusing on critical data identification and reporting.
- Lead pre-approval and routine regulatory inspection readiness activities, including strategy development and program management.
- 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 requirements and inspection readiness processes.
- Ability to lead audits and manage CAPAs effectively.
- Familiarity with oncology clinical trials is preferred.
- Excellent problem-solving skills and adaptability.
- Strong collaboration and communication 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.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy.
.png)
