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.
• Manage the internal GCP audit program.
• Identify the need for and organize ‘for cause’ audits, as required.
• 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.
• 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.
Knowledge and Skills:
• Demonstrated experience in the drug development process (early through late stages), study design, data and trial management procedures.
• Proven understanding of clinical trial-related concepts and practices, as well as GCP and regulatory standards.
• Demonstrated ability to define and implement procedures which ensure compliance to GCP and regulatory standards.
• Strong analytical and writing skills to identify and solve problems and document them appropriately.
• Ability to collaborate in decision making, as well as exercise independent judgment, supported by the ability to appropriately to use each approach.
• Interpersonal skills recognized to be collaborative, cooperative, rational, pragmatic, balanced, logical and realistic.
• Working knowledge of regional, national and international regulations and guidelines in the clinical and non-clinical areas, including GLP.
• Experience in preparation and submission activities, specifically in relation to GCP, for regulatory filings in USA and EU. Similar experience for regulatory filings in Rest of World is desired.
• Ability to manage multiple projects and assignments in a demanding fast-paced environment.
• Ability to appropriately prioritize work assignments.
• Excellent oral and written communication skills for effectively interfacing with other departments within the company, vendors, investigator sites and others.
• Ability to influence others as part of a collaborative team.
• Proven skills in documentation management practices.
• Demonstrated audit conduct and management experience is required.
• Familiarity with data processing methods.
• General knowledge of clinical medicine, oncology, and medical terminology.
• At least five years of experience in a clinical compliance or clinical quality assurance role within a drug development setting required.
• Bachelor’s or master’s degree in a scientific or life sciences discipline, or equivalent.
• GCP auditing experience required.
This is an office based position with extensive travel, including international travel.