Clinical Program Manager

SOCRA Certification

FAC-P/M Certification

FAC-COR Certification

PMP Certification

Association of Clinical Research Professionals (ACRP)

Health and Medical Administrative Services

Nursing

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

Monthly Activity Report — Monthly

Portfolio Status Report — Monthly

Risk Management Report — Monthly

Financial Status Report — Monthly

Regulatory Tracking Report — Monthly

Strategic Planning Support Reports — Ad-Hoc

Annual Program Summary Report — Yearly

Final Contract Summary Report — Ad-Hoc

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

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