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Компаниядағы жұмыс орындары

Regulatory Operations Manager, Clinical Trials

Lead clinical trial activation and regulatory compliance for the WVU Cancer Institute. Supervise staff, improve research operations, and manage regulatory activities across study lifecycles.

USАмерика Құрама ШтаттарыVAВиргинияWVБатыс ВиргинияАраласТолық жұмыс күніОрта деңгейАға маманҚажетті Тіл: ағылшын тіліОперациялар

Сипаттама

  • Lead operational and supervisory oversight for protocol activation and ongoing regulatory management of industry-sponsored and cooperative-group clinical trials
  • Manage the regulatory lifecycle from site selection and feasibility through activation, maintenance, and closeout
  • Supervise assigned staff through performance management, work allocation, workload balancing, leave approval, and professional development
  • Support recruitment, selection, onboarding, training, and performance management for assigned staff
  • Define and uphold measurable performance expectations and operational standards
  • Provide mentorship and subject-matter guidance on study activation, regulatory requirements, protocol management, sponsor expectations, and clinical research operations
  • Address complex operational and regulatory issues with CRU leadership and institutional partners
  • Create standardized workflows, tools, and training materials for regulatory operations
  • Assess operational performance and identify opportunities for process improvement, resource allocation, and workflow optimization
  • Contribute to CRU SOPs, policies, performance metrics, and quality-control programs
  • Direct site selection, feasibility assessment, and clinical trial activation
  • Coordinate regulatory, operational, financial, scientific, IRB, ancillary review, coverage analysis, budget, contract, and readiness requirements
  • Set and track activation timelines, workload, and portfolio-level performance measures
  • Guide Activation Project Managers and oversee documentation in CTMS and other research systems
  • Coordinate communication among investigators, sponsors, CROs, CRU staff, and institutional departments
  • Evaluate activation performance and report pipeline activity, timelines, workload, barriers, and operational results to leadership
  • Manage ongoing regulatory oversight for active clinical research studies
  • Create and monitor processes for amendments, continuing and annual reviews, personnel changes, regulatory document maintenance, study closures, and related obligations
  • Ensure regulatory changes are submitted, tracked, implemented, and documented on schedule
  • Oversee regulatory records in electronic regulatory, CTMS, IRB, sponsor, and cooperative-group systems
  • Interpret and apply federal regulations, IRB standards, institutional policies, sponsor requirements, and cooperative-group procedures
  • Coordinate regulatory support for monitoring visits, audits, inspections, and external reviews
  • Track regulatory workload, portfolio status, and key performance indicators for CRU leadership
  • Partner with investigators and study teams to implement regulatory changes and study requirements
  • Promote regulatory compliance through staff education, quality control, process improvement, and collaboration with CRU Compliance
  • Manage the transition from activation to ongoing regulatory oversight and timely study closeout

Талаптар

  • Bachelor’s degree in a relevant field and at least three years of experience
  • At least three years of experience in clinical research coordination, regulatory operations, project management, or a related area
  • Equivalent combinations of relevant education and experience may be considered
  • Ability to manage concurrent studies and priorities, assess operations, identify obstacles, and implement improvements
  • Strong project management capabilities, including planning, prioritization, delegation, risk assessment, problem solving, and timeline and deliverable management
  • Ability to interpret complex protocols, regulations, policies, and sponsor requirements and convert them into operational processes and staff guidance
  • Proficiency with clinical trial management, electronic regulatory, IRB, and other clinical research information systems
  • Strong written and verbal communication, consultation, and interpersonal abilities
  • 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 discipline
  • Preferred: At least three years of progressively responsible clinical research experience in an academic medical center, cancer center, research institution, or industry setting
  • Preferred: Strong understanding of federal regulations, ICH Good Clinical Practice, IRB requirements, and institutional policies for human-subject research
  • Preferred: Experience activating clinical trials, including site selection, feasibility, regulatory startup, IRB submissions, ancillary reviews, and budget, contract, and coverage analysis coordination
  • Preferred: Experience managing ongoing clinical trial regulations, including amendments, continuing review, document maintenance, sponsor monitoring, audits, and closeout
  • Preferred: Experience with industry-sponsored and National Cancer Institute NCTN/ECTCN cooperative-group trials and their regulatory and operational requirements
  • Preferred: Experience supervising teams, leading projects, or coordinating the work of others

Артықшылықтар

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

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