Manager Clinical Trials Office Regulatory

Responsible for providing over-sight and quality control of regulatory data management in the Clinical Trials Office (CTO) of the Barbara Ann Karmanos Cancer Institute. Under the direction of the Director, Clinical Trials Regulatory and Data Services, the individual is responsible for management oversight of regulatory personnel. This includes new staff recruitment, hiring, discipline and the ongoing daily management of staff.

Responsibilities:

• Coordinates the orientation program for new Regulatory Clinical Research Coordinators. Updates orientation documentation as indicated with changes in internal/external regulations in the conduct of clinical research.
• Provides administrative support to Protocol Review Committee and use of ePRMS within OnCore.
• Provides oversight in the coordination of regulatory assignments. Directly supervises regulatory supervisors. Approves/rejects projects as indicated.
• Analyze research data and prepare statistical reports related to clinical trials regulatory staff performance.
• Implements and maintains a Quality Assurance Program for regulatory data management which includes adherence to Standard Operating Procedures, Food and Drug Administration guidelines, ICH, and Good Clinical Practice. Ensures compliance to both internal and external regulatory guidelines.

• Bachelor's degree required, Master's degree preferred.. Demonstrated leadership skills required. Regulatory experience required.
• Prior management experience monitoring day-to in hiring, training, discipline in over-sight of patient and regulatory data Research Assistants preferred.
• Knowledgeable in internal/external regulations, Good Clinical Practice in the conduct of clinical trials, research budgets, federal grant requirements, etc.
• SoCRA certification or equivalent required.

Equal Opportunity Employer of Minorities/Females/Disabled/Veterans