Clinical Program Manager

GAP Solutions Inc; Bethesda (MD); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Accommodations available for disabled

Job summary

GAP Solutions Inc. seeks a Clinical Program Manager to support the National Cancer Institute within NIH. You will oversee clinical research portfolios, coordinate with investigators, regulatory offices, data managers, and clinical teams to ensure milestones are met on time.

The role requires strong project management, risk mitigation, and communications skills to align activities with organizational goals and regulatory requirements.

Qualifications

• Master’s degree required in health/medical admin or nursing.
• SOCRA, FAC-P/M, FAC-COR, PMP, and ACRP certifications preferred.
• Experience with clinical trial management systems and research databases.
• Experience with NIH/NCI or federally funded research programs is highly desirable.

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.

Skills

SOCRA Certification

FAC-P/M Certification

FAC-COR Certification

PMP Certification

ACRP Certification

CTMS experience

Research databases

Education

Master’s Degree in Health and Medical Administrative Servies, Nursing, or similar field of study

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 research programs

Preferred Qualifications

• 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

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at [e-mail] . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.

This position is contingent upon contract award.