Title: Regulatory Project Manager
Location: New Haven, CT
Duration: Direct Hire
Schedule: M-F 37.5 hours
Target Start Date: As soon as possible
Note: “Candidates that require sponsorship are welcome to apply”
• Supervise day to day work activities of assigned regulatory staff, including delegation of work units and managing staff workload through communication of job expectations, planning, monitoring, and evaluation of work product.
• Provide quality reviews and oversight functions for all institutional review board (IRB)submissions and post-approvals to ensure regulatory integrity, while evaluating submission metrics and staff feedback to identify gaps in efficiency.
• Manage regulatory compliance activities related to quality control, including audit preparation, responses related to regulatory findings, reportable events, corrective actions, and other special projects related to efficiency and compliance within the regulatory department.
• Maintain regulatory compliance and project management for single-center Investigator- Initiated Clinical Trials where the IND is held by an Investigator. Liaise with IND Coordinator to ensure compliance with Code of Federal Regulations.
• A minimum of a BA/BS degree or equivalent with 5 years regulatory experience (e.g., research, clinical, interaction with study population, program coordination) and 3 years supervisory experience. Advanced knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations. ACRP/SoCRA (or equivalent) certification preferred; Master’s level preparation preferred.
• Ability to lead regulatory personnel in a large, multi-study oncology-specific workload portfolio and assure compliance with regulatory agencies
• Ability to prioritize the oncology-specific workload of a large, multi-study portfolio, with multiple DART-specific responsibilities.
• Ability to maintain compliant processes and workflows supporting a large, multi-study oncology protocol portfolio. Ability to participate in and help lead quality control and educational efforts within a large oncology regulatory department