(Hybrid) Regulatory Operations Manager - WVU Cancer Institute

West Virginia University • West Virginia, WV

2d • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree in appropriate areas of specialization and three years of experience
• A minimum of three (3) years of experience in the following: Clinical research coordination, regulatory operations, and/or project management
• Any equivalent combination of related education and/or experience will be considered.
• All qualifications must be met by the time of employment.
• Ability to manage multiple concurrent studies and priorities, evaluate operational performance, identify barriers, and implement process improvements.
• Strong project-management skills, including planning, prioritization, delegation, risk identification, problem solving, and management of timelines and deliverables.
• Ability to interpret complex protocols, regulations, policies, and sponsor requirements and translate them into operational processes and staff guidance.
• Proficiency with clinical trial management systems, electronic regulatory systems, IRB platforms, and other clinical research information systems.
• Strong written and verbal communication, consultation, and interpersonal skills, with the ability to collaborate effectively with investigators, research staff, institutional departments, sponsors, CROs, and external partners.
• Sound professional judgment and discretion, with the ability to work independently, make decisions, and manage competing priorities in a complex clinical research environment.

Nice To Haves

• Master’s degree in Clinical Research, Health Sciences, Basic Sciences, Healthcare Administration, or a related field.
• Three or more years of progressively responsible clinical research experience in an academic medical center, cancer center, research institution, or industry setting.
• Strong knowledge of federal regulations, ICH Good Clinical Practice, Institutional Review Board requirements, and institutional policies governing human-subject clinical research.
• Experience with clinical trial activation, including site selection and feasibility, regulatory startup, IRB submissions, ancillary reviews, and coordination of budget, contract, and coverage analysis activities.
• Experience with ongoing regulatory management of clinical trials, including protocol amendments, continuing review, regulatory document maintenance, sponsor monitoring, audits, and study closeout.
• Experience with industry-sponsored and National Cancer Institute NCTN/ECTCN cooperative-group clinical trials and associated regulatory and operational requirements.
• Supervisory, team leadership, project leadership, or other experience coordinating the work of others preferred.

Responsibilities

• 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.
• Oversees site selection and feasibility activities for prospective clinical trials, coordinating study opportunities with investigators, disease teams, sponsors, and applicable CRU functions.
• Oversees protocol activation activities and coordination of regulatory, operational, financial, and institutional startup requirements, including applicable scientific review, IRB review, ancillary reviews, coverage analysis, budget and contract processes, and operational readiness.
• Establishes and monitors study activation timelines, workload, and portfolio-level performance metrics; identifies barriers and intervenes or escalates as necessary to support timely activation.
• Provides guidance and serves as an escalation resource to Activation Project Managers regarding sponsor requirements, institutional processes, regulatory requirements, and complex startup issues.
• Oversees use of the CTMS and other research systems to ensure accurate and consistent documentation of study status, milestones, and activation requirements.
• Facilitates communication with investigators, sponsors, CROs, CRU personnel, and institutional departments to resolve startup issues and maintain transparency regarding study progress.
• Analyzes activation performance and provides reports to CRU and Cancer Institute leadership regarding study pipeline, activation timelines, workload, barriers, and operational performance.
• Leads continuous improvement of activation processes to improve efficiency and reduce activation timelines while maintaining regulatory and institutional compliance.
• Oversees regulatory maintenance of the CRU clinical trial portfolio and serves as a senior resource and backup for Regulatory Coordinators.
• Establishes and monitors workflows and timelines for protocol amendments, continuing/annual reviews, investigator and study personnel updates, regulatory document maintenance, study closures, and other ongoing regulatory requirements.
• Ensures timely submission, tracking, implementation, and documentation of protocol amendments and other regulatory changes.
• Oversees accurate and complete regulatory documentation and study information within applicable electronic regulatory, CTMS, IRB, sponsor, and cooperative-group systems.
• Provides guidance regarding interpretation and application of federal regulations, IRB requirements, institutional policies, sponsor requirements, and applicable cooperative-group procedures governing human-subject research.
• Serves as an escalation resource for regulatory issues involving investigators, sponsors, CROs, IRBs, institutional departments, and research staff.
• Coordinates regulatory support for sponsor monitoring visits, audits, inspections, and other external reviews and ensures identified issues are appropriately addressed and escalated.
• Monitors regulatory workload, portfolio status, and key performance indicators and provides reports to CRU leadership regarding active-study regulatory activity and performance.
• Collaborates with investigators and study teams to communicate and implement regulatory changes and other study requirements.
• Supports identification, resolution, and prevention of regulatory compliance issues through staff education, quality-control activities, process improvement, and coordination with CRU Compliance as appropriate.
• Oversees transition of studies from activation to ongoing regulatory management and ensures timely regulatory closeout.

Benefits

• 37.5-hour work week
• 13 paid holidays (staff holiday calendar)
• 24 annual leave (vacation) days per year (employee leave)
• 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)
• WVU offers a range of health insurance and other benefits
• 401(a) retirement savings with 6%25 employee contribution match, eligibility to continue health insurance, and other retiree perks.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager