Clinical Program Manager

Axle•Bethesda, MD

21h•$140,000 - $150,000•Onsite

About The Position

Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH). Axle is seeking a Clinical Program Manager to join our vibrant team at the National Institutes of Health (NIH) supporting the National Cancer Institute (NCI) located in Bethesda, MD.

Requirements

Master's degree
Experience with clinical trial management systems and research databases
Experience with technology transfer agreements, clinical trial agreements, cooperative research and development agreements, or related research partnerships
Experience supporting NIH, NCI, academic medical centers, or federally funded research programs

Nice To Haves

SOCRA Certification
FAC-P/M Certification
FAC-COR Certification
PMP Certification
Association of Clinical Research Professionals (ACRP)
Health and Medical Administrative Services
Nursing
Software

Responsibilities

Coordinate operational activities for clinical studies
Assist with feasibility assessments for proposed clinical trials
Support startup activities for new studies
Coordinate participating sites for multi-center trials
Monitor study progress and enrollment-related metrics
Facilitate communication among study stakeholders
Provide comprehensive management and oversight of assigned clinical research portfolios
Develop and maintain project management plans for clinical research projects
Monitor project schedules, timelines, deliverables, dependencies, and milestones
Track portfolio performance metrics and report progress to leadership
Assist Branch Chiefs and Program Leadership in prioritization of research activities
Support portfolio planning and resource allocation efforts
Monitor project execution to ensure alignment with organizational objectives
Lead development and maintenance of project-specific work plans
Coordinate project initiation, planning, execution, monitoring, and closeout activities
Facilitate project meetings and maintain meeting documentation
Track action items and follow-up activities
Monitor project performance and identify potential barriers to success
Assist investigators and research teams in achieving project objectives
Develop risk mitigation and response plans
Monitor identified risks throughout the project lifecycle
Escalate significant issues to leadership as appropriate
Coordinate corrective actions and resolution activities
Identify operational, regulatory, financial, and programmatic risks
Monitor and coordinate activities associated with protocol development, protocol amendments, Institutional Review Board (IRB) submissions, regulatory submissions, continuing reviews, study activation activities, and clinical trial monitoring activities
Support preparation for audits, inspections, and monitoring visits
Coordinate activities among investigators, regulatory staff, data managers, and clinical teams
Monitor compliance-related milestones and deliverables
Facilitate timely submission of required regulatory documents
Assist with development of project-specific budgets
Monitor expenditures and financial performance
Track project funding and resource utilization
Develop financial forecasts
Identify potential budgetary concerns and recommend corrective actions
Prepare financial status reports for leadership review
Serve as liaison between assigned research programs and the Office of the Clinical Director (OCD), NCI Technology Transfer Center, regulatory offices, collaborating institutions, industry partners, and other NIH and NCI organizations
Coordinate leadership briefings and status updates
Prepare communication materials and project summaries
Assist Government personnel with development of Statements of Work
Assist with technical evaluations and acquisition planning activities
Track contractor performance, deliverables, and invoice status
Monitor contract milestones and option periods
Support COR activities as requested
Support strategic planning initiatives
Analyze program performance and operational effectiveness
Develop recommendations for process improvements
Assist leadership with prioritization of future research initiatives
Support implementation of organizational best practices