Description
Roles and Responsibilities:- Manage the clinical quality assurance program, which includes the development and execution of quality plans for each study, as well as auditing of investigator sites, vendors, databases and clinical study reports. which includes but is not limited to:
- Develop and execute cGCP audit plans to the agreed timelines and deliverables.
- Ensure independent audits of clinical sites, CROs, central laboratories, and other vendors which support the clinical development program.
- Issue audit reports with findings.
- Collaborate with Clinical Operations colleagues to develop and ensure closure of CAPA plans to address audit findings.
- Issue audit certificates.
- Develop and maintain audit documentation and files.
- Develop and maintain audit metrics.
- Manage the internal GCP audit program., which includes but is not limited to:
- Develop and execute the internal cGCP audit plans to the agreed timelines and deliverables.
- Issue internal cGCP audit reports with findings.
- Collaborate with colleagues to ensure closure of internal cGCP audit CAPA plans developed to address audit findings.
- Issue internal cGCP audit certificates.
- Develop and maintain internal cGCP audit documentation and files.
- Develop and maintain internal cGCP audit metrics.
- Identify the need for and organize 'for cause' audits, as required., which includes but is not limited to:
- Lead and manage regulatory inspection readiness activities.
- Act as inspection host, as required.
- Ensure conduct of the inspection complies with company procedures.
- Coordinate preparation of responses to the inspection reports.
- Oversee completion of the CAPA plans resulting from the inspections.
- Develop and maintain inspection documentation and files.
- Develop and maintain inspection metrics.
- Interact with Clinical Development and Clinical Operations staff to ensure understanding and agreement of audit priorities.
- Manage the resources required to execute the clinical quality assurance program and to support audit activities by personally conducting audits and/or overseeing the conduct of audits by contract auditors, as appropriate.
- Ensure inspection readiness for regulatory authority GCP inspections, both routine and pre-approval inspections, of the company (as sponsor) and associated investigator sites by personally planning and executing inspection readiness activities and/or overseeing the planning and execution by consultants, as appropriate.
- Develop and implement clinical compliance programs.
- Identify clinical trial-related risks and implement mitigation strategies.
- Provide rational and pragmatic guidance for handling and resolving departures, deviations or breaches to GCP standards.
- Provide balanced, logical and realistic advice to the clinical team for dealing with clinical trial-related issues.
- Consult internally on cGCP compliance issues ensuring the provision of timely guidance and appropriate resolution.
- Ensure reviews and quality (QC) audits of clinical documentation and submissions, including protocols, investigator brochures, informed consent forms, case report forms and study reports by personally conducting the reviews and quality (QC) audits and/or overseeing these activities performed by contractors, as appropriate.
- Support the clinical and non-clinical functional departments which include but are not limited to the following departments: Clinical Development, Clinical Operations, Biostatistics, Data Management, Safety, Translational Medicine and Molecular Diagnostics.
- Ensure the clinical and non-clinical functional departments have appropriate Standard Operating Procedures to maintain compliance to corporate, regional, national and international standards.
- Draft assigned standard operating procedures and work instructions.
- Develop and conduct GCP training internally and at investigator meetings, as required.
- Monitor for updates to current regulations and guidances at regional, national and international levels and ensure the appropriate staff is informed of and prepared to comply with the changes, as required.
- Ensure documentation supporting GCP compliance activities is maintained in accordance with company and industry standards.
- Participate on cross-functional teams, as needed.
- Report to supervisor on project progress, issues and problem solving.
- Support other objectives, as assigned.