Clinical Program Manager

GAP Solutions Inc; Maryland; On-site; USD 110,000 - 170,000; Full time

Job summary

GAP Solutions Inc. seeks a Clinical Program Manager to support the National Cancer Institute within NIH. The role requires coordinating complex clinical research portfolios, managing timelines, resources, and regulatory submissions across investigators, data managers, and oversight offices.

The candidate will develop risk and budget plans, monitor milestones, and report progress to leadership. Strong collaboration with branches and external partners is essential for successful trial activation

Qualifications

• Master's degree or higher in health admin, nursing, or related field required.
• SOCRA, FAC-P/M, FAC-COR, PMP, or ACRP certifications preferred.
• Experience with clinical trial management systems and related research databases required.

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, IRB submissions, regulatory submissions, continuing reviews, study activation, and clinical trial monitoring.
• 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 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 budgetary concerns and recommend corrective actions.
• Prepare financial status reports for leadership review.
• Serve as liaison between assigned research programs and OCD, NCI Technology Transfer Center, regulatory offices, collaborating institutions, industry partners, and other NIH/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

Education

Master's Degree in Health and Medical Administrative Services, Nursing, or similar field of study

SOCRA Certification

FAC-P/M Certification

FAC-COR Certification

PMP Certification

Association of Clinical Research Professionals (ACRP)

Experience with clinical trial management systems

Experience with technology transfer agreements, clinical trial agreements, and cooperative research and development agreements

Job description

Position Objective:

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.

Duties and 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 1
• Assist with feasibility assessments for proposed clinical trials 2
• Support startup activities for new studies 3
• Coordinate participating sites for multi-center trials 4
• Monitor study progress and enrollment-related metrics 5
• 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

Qualifications

Basic Qualifications:

• 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