WVU Medicine

(Hybrid) Regulatory Operations Manager - WVU Cancer Institute

WVU Medicine • $80K — $95K *
Morgantown, WV 26505Hybrid
Healthcare
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a relevant field and three years of experience
  • Minimum of three years in clinical research coordination, regulatory operations, or project management
  • Ability to manage multiple studies and implement process improvements
  • Strong project management skills including planning and risk identification
  • Proficiency with clinical trial management systems and electronic regulatory systems

Responsibilities

  • Provide operational oversight of protocol activation and regulatory management for clinical trials
  • Supervise and manage staff involved in protocol activation and management activities
  • Establish performance expectations and operational standards for regulatory operations
  • Oversee site selection and feasibility for clinical trials
  • Monitor study activation timelines and intervene to support timely activation
  • Ensure accurate regulatory documentation and compliance throughout the study lifecycle
  • Coordinate regulatory support for audits and external reviews

Benefits

  • Hybrid work environment
  • Professional development opportunities
  • Mentorship and technical guidance
  • Collaboration with a multidisciplinary team
  • Contribution to impactful cancer research initiatives
Full Job Description
Description

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

About the Opportunity

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.

What You'll Do

  • 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 institutional startup requirements and study activation. Responsibilities include:
    • 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.
  • Protocol Management & Regulatory Oversight
    • Provides oversight of regulatory management activities for active clinical research studies from activation through study closure. Responsibilities include:
      • 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.


Qualifications

  • 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.


Knowledge, Skills, and Abilities

  • 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.


Preferred Qualifications:

  • 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.

About WVU Medicine

West Virginia University Health System is a non-profit organization that offers a full range of healthcare services.

WVU Medicine Careers

There has never been a better time to explore the diverse job opportunities at WVU Medicine, the premier destination for top-tier healthcare professionals. As the largest healthcare provider in West Virginia, WVU Medicine is at the forefront of medical innovation and patient care.

Work You’ll Do

Join WVU Medicine’s esteemed team to assist in transforming healthcare across the region. This is an opportunity to be part of a culture that values growth, leadership, and professional development. Engage in meaningful work that makes a difference, leveraging the latest in medical technology and practices. WVU Medicine positions itself uniquely at the nexus of patient care, research, and education, making it a pivotal platform for career advancement in the healthcare industry.

WVU Medicine Job Opportunities

The team is actively building a robust employment infrastructure to support some of the most well-known communities in healthcare. WVU Medicine offers a variety of positions, from clinical roles to administrative support, ensuring a fit for a wide range of skills and interests.

Innovate and Lead

At WVU Medicine, innovation isn’t just a buzzword—it's a practical part of daily operations. The company is home to a dynamic team of over 20,000 dedicated professionals who bring groundbreaking medical treatments and technologies to life.

Cultivate Your Career

WVU Medicine is committed to fostering a workplace where every team member can thrive. Employees enjoy comprehensive benefits, diversity training, and numerous channels for professional growth through leadership development programs and internships.

Explore WVU Medicine

From implementing advanced electronic medical records to enhancing patient care protocols, WVU Medicine is a leader in healthcare innovation. The company’s commitment to excellence is evident in its proactive approach to healthcare challenges and its continuous pursuit of improvement.

The WVU Medicine Experience

WVU Medicine’s collaborative environment is ideal for those who are driven to excel in their careers and make a significant impact in healthcare. The company’s emphasis on teamwork and networking creates a strong foundation for personal and professional development.

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Learn more about WVU Medicine
Size
10,001 employees
Industry
Hospitals & Medical Centers
* Ladders Estimates

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