ASSOC DIRECTOR E
Duties: * Develop, implement and maintain the local Quality Systems in the areas of GCP and Pharmacovigilance (PV) in accordance with the University of Pennsylvania and Translational Research Program (TRP) procedures and the applicable regulatory requirements (FDA, NIH, NCI, etc).
* Plan and oversee GCP audit program of investigator sites, clinical studies, safety reporting, suppliers, and documents being performed by the Translational Research Program (TRP) within the Abramson Cancer Center (ACC).
* Plan and oversee the development and implementation of a Standard Operating Procedures (SOPs) management system.
* Provide leadership in SOP Management system, in the identification and development of Standard Operating Procedures, related to clinical trials and clinical activities from conception through implementation and training.
* Provide Leadership and guidance in establishing the GCP Training Management program. Ensure the training needs are identified and training is implemented to current procedures, regulations and guidance.
* Ensure the training is conducted based on audit trend analysis, monitoring, new and revised SOPs, etc.
* Manage, provide technical guidance, leadership, coaching, and training of GCP auditors and SOP development and training personnel.
* Review and approve the Study Audit Summary reports. Coordinate answers of the auditors, provide guidance in determining observations' root causes and ensure that appropriate corrective and preventive actions are implemented for all major and critical audit findings.
* Provide leadership to drive closure of audits through close collaboration with auditees, involved business units, Investigator sites and partners.
* In cooperation with the GMP QA Unit ensure analysis, assessment and resolution (including CAPAs where indicated) of issues with common interfaces.
* Assist Director, Clinical QA, with preparation for potential regulatory inspections and hosting regulatory inspections of investigator sites and other GCP projects.
* Facilitate the ongoing improvement of clinical compliance and GCP Quality Assurance through communication of audit results and compliance guidance.
* Oversee external and internal (Clinical Operations, Data Management and Pharmacovigilance) quality GCP programs in accordance with organizational and industry quality standards and regulations. This individual will work to implement new and improve upon current quality systems and workflows.
* Develop and Report monthly Key Quality Indicators (KQIs) related to clinical activities to QA and Senior Management and monitor them to assure that gaps are addressed appropriately in order to mitigate risk.
* Provide support and proactive, strategic planning for QA oversight of clinical development activities.
* Liaison between Quality and Clinical Operations, Data Management, and Regulatory functions.
* Ensure operations in clinical development are compliant with FDA, ICH, NIH/NCI and industry standards.
* Oversee GCP training both for TRP and clinical sites.
* Review and advise on relevant guidelines, policies, Internal Procedures and Standard Operating Procedures (SOPs)
Qualifications: * Master's degree and 5 to 7 years of pharmaceutical industry/GCP auditing experience or equivalent combination of education and experience is required.
* The position requires growing experience in clinical research related activities (e.g., monitor, study coordinator, or similar experience) and a proven record in GCP auditing activities. An in-depth knowledge and experience in the application of Good Clinical Practice (GCP) requirements is required (e.g., ICH, FDA, NIH/NCI, etc.). Familiarity with the essential documents related to clinical studies, medical terminology and routine medical tests and procedures. Familiarity with computerized clinical data collection systems and biomedical statistics is needed.
* Staff supervisory experience required.
* The candidate must possess strong interpersonal, oral and written communication skills in order to effectively and independently oversee and conduct audits and communicate results.
* Strong ability to demonstrate diplomacy and negotiation skills, as well as the ability to persuade when necessary. Able to confidently interact with all levels of management including senior management, PI's and others.
* The ability to develop interdepartmental relationships and form solid collaborations is critical.
* Strong sense of urgency in escalating non-compliance issues.
* Adept in the use of computerized databases and other applications and in performing data analyses to evaluate trends and metrics.
* The candidate must be able to assimilate large amounts of data efficiently, exercise sound judgment and maintain composure in order to effectively handle sensitive issues, such as instances of serious clinical noncompliance.
* Proven project management skills, including effective planning and organizational skills, attention to detail and excellent follow through.
Position contingent upon funding.
Reference Number: 40-17215
Salary Grade: 029
Employment Type: Exempt
Org: CC-Cancer Center
Special Requirements: Background Check Required
Job Family: B-Executive/Managerial Administration