Regulatory Operations Manager

WVU Online

. Provide operational and supervisory oversight of protocol activation and ongoing regulatory management for industry-sponsored and cooperative-group clinical trials .

Posted 10/2/2026full-timeUnited StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research operations, regulatory management, and project oversight, with a strong focus on compliance, performance evaluation, and staff development. Proficient in managing multiple clinical trials while ensuring adherence to federal regulations and institutional policies.

Highest-signal resume keywords

Clinical Research CoordinationRegulatory OperationsProject ManagementClinical Trial Management SystemsFederal Regulations Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Protocol ManagementRegulatory CompliancePerformance Metrics EvaluationProcess ImprovementBudget CoordinationIRB SubmissionsStudy CloseoutWorkflow OptimizationRisk IdentificationOperational Standards

Soft Skills

Strong CommunicationInterpersonal SkillsProfessional JudgmentProblem SolvingTeam Leadership

Tools & Technologies

Electronic Regulatory SystemsCTMSIRB PlatformsClinical Research Information Systems

Industry Keywords

Good Clinical PracticeHuman-Subject ResearchCancer Center TrialsCooperative-Group Clinical TrialsOperational Readiness

About the role

Key responsibilities & impact

Provide operational and supervisory oversight of protocol activation and ongoing regulatory management for industry-sponsored and cooperative-group clinical trials
Oversee the regulatory lifecycle from site selection and feasibility through study activation, maintenance, and closeout
Supervise assigned staff, including performance management, work assignments, workload assessment and redistribution, time and leave approvals, and professional development
Participate in recruitment, selection, onboarding, training, and performance management of assigned staff
Establish and reinforce measurable performance expectations and operational standards
Provide mentorship, technical guidance, and subject-matter expertise on study activation, regulatory requirements, protocol management, sponsor requirements, and clinical research operations
Resolve complex operational and regulatory issues with CRU leadership and institutional partners
Develop standardized workflows, tools, and training resources for regulatory operations
Evaluate operational performance and identify process improvement, resource allocation, and workflow optimization opportunities
Participate in CRU SOPs, policies, performance metrics, and quality-control activities
Oversee site selection, feasibility, and activation of clinical trials
Coordinate regulatory, operational, financial, scientific review, IRB, ancillary review, coverage analysis, budget, contract, and operational readiness requirements
Establish and monitor activation timelines, workload, and portfolio-level performance metrics
Guide Activation Project Managers and oversee CTMS and research-system documentation
Facilitate communication with investigators, sponsors, CROs, CRU personnel, and institutional departments
Analyze activation performance and report study pipeline, timelines, workload, barriers, and operational performance to leadership
Oversee regulatory maintenance for active clinical research studies
Establish and monitor workflows for protocol amendments, continuing/annual reviews, personnel updates, regulatory document maintenance, study closures, and other ongoing requirements
Ensure timely submission, tracking, implementation, and documentation of regulatory changes
Oversee regulatory documentation in electronic regulatory, CTMS, IRB, sponsor, and cooperative-group systems
Interpret and apply federal regulations, IRB requirements, institutional policies, sponsor requirements, and cooperative-group procedures
Coordinate regulatory support for monitoring visits, audits, inspections, and external reviews
Monitor regulatory workload, portfolio status, and key performance indicators and report to CRU leadership
Collaborate with investigators and study teams to implement regulatory changes and study requirements
Support regulatory compliance through staff education, quality control, process improvement, and coordination with CRU Compliance
Oversee transition from activation to ongoing regulatory management and timely regulatory closeout

Requirements

What you’ll need

Bachelor’s degree in appropriate areas of specialization and three years of experience
Minimum of three (3) years of experience in clinical research coordination, regulatory operations, and/or project management
Any equivalent combination of related education and/or experience will be considered
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
Sound professional judgment and discretion, with the ability to work independently, make decisions, and manage competing priorities
Preferred: Master’s degree in Clinical Research, Health Sciences, Basic Sciences, Healthcare Administration, or a related field
Preferred: Three or more years of progressively responsible clinical research experience in an academic medical center, cancer center, research institution, or industry setting
Preferred: Strong knowledge of federal regulations, ICH Good Clinical Practice, Institutional Review Board requirements, and institutional policies governing human-subject clinical research
Preferred: 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
Preferred: Experience with ongoing regulatory management of clinical trials, including protocol amendments, continuing review, regulatory document maintenance, sponsor monitoring, audits, and study closeout
Preferred: Experience with industry-sponsored and National Cancer Institute NCTN/ECTCN cooperative-group clinical trials and associated regulatory and operational requirements
Preferred: Supervisory, team leadership, project leadership, or other experience coordinating the work of others

Benefits

Comp & perks

37.5-hour work week
13 paid holidays
24 annual leave (vacation) days per year
18 sick days per year
Health insurance and other benefits
401(a) retirement savings with 6% employee contribution match
Eligibility to continue health insurance and other retiree perks
Wellness programs