Clinical Program Manager (52096)

GAP SOLUTIONS INC•Bethesda, MD

18d•$125,000 - $185,000•Onsite

About The Position

Provide services as a Clinical Program Manager in support of the overall functions of National Cancer Institute within the National Institutes of Health (NIH). The Clinical Program Manager shall provide personnel capable of supporting complex clinical research portfolios and ensuring efficient coordination among investigators, research teams, oversight offices, regulatory agencies, collaborating institutions, and other stakeholders involved in the conduct of clinical research.

Requirements

Master’s Degree in Health and Medical Administrative Servies, Nursing, or similar field of study.
Required certifications/licenses: SOCRA Certification, FAC-P/M Certification, FAC-COR Certification, PMP Certification, Association of Clinical Research Professionals (ACRP)
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

Ability to communicate effectively, orally and in writing, with non-technical and technical staff
Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

Responsibilities

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; 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
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
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: Office of the Clinical Director (OCD); NCI Technology Transfer Center; Regulatory offices; Collaborating institutions; Industry partners; Other NIH and NCI organizations
Facilitate communication among project stakeholders
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.
Monthly Activity Report
Monthly Portfolio Status Report
Monthly Risk Management Report
Monthly Financial Status Report
Monthly Regulatory Tracking Report
Monthly Strategic Planning Support Reports
Annual Program Summary Report
Yearly Final Contract Summary Report