Hybrid) Regulatory Operations Manager - WVU Cancer Institute

Job Description - (Hybrid) Regulatory Operations Manager - WVU Cancer Institute (30279)

(Hybrid) Regulatory Operations Manager - WVU Cancer Institute 30279

Description

The Cancer Institute at West Virginia University is currently accepting applications for a (Hybrid) Regulatory Operations Manager.

The Regulatory Operations Manager provides operational and supervisory oversight of protocol activation and ongoing regulatory management activities for industry-sponsored and cooperative-group clinical trials conducted through the WVUCI CRU. The position oversees the regulatory lifecycle from site selection and feasibility through study activation, maintenance, and closeout, ensuring timely study startup, compliant ongoing study management, effective workload distribution, and consistent application of institutional and regulatory requirements.

This highly visible role includes joint responsibility and accountability with other Directors and Managers within the CRU for the success of WVUCI clinical trials operations and for continuous improvement in the quality and efficiency of the clinical research program.

We strongly believe in work-life balance and keeping time for things we love outside our work. WVU offers generous benefits, including:

• 18 sick days per year(for when you're ill, for when you need time to care for sick family, for your own, or your family's, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof)
• 401(a) retirement savings with 6% employee contribution match, eligibility to continue health insurance, and other retiree perks. Looking for more retirement benefits information ? Check out retirement health insurance benefits, retirement income, and FAQ's.
• Wellness programs

• Regulatory Operations Leadership & Staff Management
  • Incumbent is responsible for the supervision, management, and operational oversight of staff assigned to protocol activation and protocol management activities within the CRU.
    
    Responsibilities include:
  • Provides direct supervision and leadership to assigned staff, including performance management, work assignments, workload assessment and redistribution, time and leave approvals, and professional development.
  • Participates in recruitment, selection, onboarding, training, and performance management of assigned staff in collaboration with CRU leadership and WVU Talent and Culture.
  • Establishes and reinforces clear, measurable performance expectations and operational standards for protocol activation and management activities.
  • Provides mentorship, technical guidance, and subject-matter expertise regarding study activation, regulatory requirements, protocol management, sponsor requirements, and clinical research operations.
  • Serves as an escalation point for complex operational and regulatory issues and coordinates resolution with CRU leadership and other institutional partners as appropriate.
  • Develops and implements standardized workflows, tools, and training resources to promote consistency, efficiency, and quality across regulatory operations.
  • Evaluates operational performance and identifies opportunities for process improvement, resource allocation, and workflow optimization.
  • Participates in development and implementation of CRU SOPs, policies, performance metrics, and quality-control activities and promotes effective coordination across CRU functional areas.
• Protocol Activation
  • Provides oversight and direction for activation of industry-sponsored and cooperative-group clinical trials from initial site selection and feasibility through completion of…