Clinical Program Manager

Guidehouse•Bethesda, MD

1d•$85,000 - $141,000•Onsite

About The Position

We are currently searching for a Clinical Program Manger to support complex clinical research programs by coordinating investigators, research teams, oversight offices, regulatory agencies, partner institutions, and other key stakeholders to ensure studies run efficiently. This is a full-time opportunity located in Bethesda, MD. Support complex clinical research portfolios by coordinating activities across investigators, research teams, regulatory bodies, and stakeholders in Bethesda, MD. Provide end-to-end project management for clinical research, including planning, execution, monitoring, and closeout of studies and portfolios. Develop and maintain project management plans, work plans, schedules, and performance metrics to track progress, timelines, deliverables, and resource allocation. Coordinate operational and startup activities for clinical trials, including feasibility assessments, site coordination for multi-center trials, and study activation. Facilitate project meetings, track action items, and ensure effective communication among stakeholders, leadership, and collaborating institutions. Monitor study progress, enrollment metrics, and portfolio performance, identifying risks, barriers, and opportunities for improvement. Support protocol development, IRB and regulatory submissions, amendments, and compliance with clinical trial requirements and milestones. Develop and implement risk management strategies, including mitigation plans and resolution of operational, regulatory, and programmatic issues. Support audits, inspections, and monitoring visits, ensuring readiness and compliance with applicable standards and guidelines. Assist with financial management activities, including budget development, expenditure tracking, forecasting, and reporting. Serve as a liaison between research programs, regulatory offices, and partners, preparing briefings, reports, and communication materials for leadership. Support acquisition planning, contractor oversight, and strategic initiatives, including performance tracking and process improvement efforts. Prepare and deliver routine and ad hoc reports such as portfolio status, risk management, financial summaries, regulatory tracking, and annual program reports.

Requirements

Master’s degree in health and medical administrative services, nursing, or a related field.
Minimum of FOUR (4) years of experience supporting clinical research programs.
Experience supporting complex clinical research portfolios and coordinating across stakeholders.
Experience with clinical trial management systems and research databases.
Experience with technology transfer agreements, clinical trial agreements, cooperative research and development agreements, or similar partnerships.
Experience supporting NIH, NCI, academic medical centers, or federally funded research programs.
Ability to manage multiple projects, timelines, and stakeholders simultaneously.
Must be able to obtain and maintain a Federal or DoD “public trust”; candidates must receive approved adjudication prior to onboarding with Guidehouse. Candidates with an active public trust or suitability are preferred.

Nice To Haves

Certifications in any of the following: SOCRA, FAC-P/M, FAC-COR, and/or PMP Certification.
Strong project management, coordination, and communication skills.
Association of Clinical Research Professionals (ACRP) certification.
Experience in clinical trial design, feasibility assessments, and regulatory processes.
Experience supporting multi-site or multi-center clinical trials.

Responsibilities

Support complex clinical research portfolios by coordinating activities across investigators, research teams, regulatory bodies, and stakeholders in Bethesda, MD.
Provide end-to-end project management for clinical research, including planning, execution, monitoring, and closeout of studies and portfolios.
Develop and maintain project management plans, work plans, schedules, and performance metrics to track progress, timelines, deliverables, and resource allocation.
Coordinate operational and startup activities for clinical trials, including feasibility assessments, site coordination for multi-center trials, and study activation.
Facilitate project meetings, track action items, and ensure effective communication among stakeholders, leadership, and collaborating institutions.
Monitor study progress, enrollment metrics, and portfolio performance, identifying risks, barriers, and opportunities for improvement.
Support protocol development, IRB and regulatory submissions, amendments, and compliance with clinical trial requirements and milestones.
Develop and implement risk management strategies, including mitigation plans and resolution of operational, regulatory, and programmatic issues.
Support audits, inspections, and monitoring visits, ensuring readiness and compliance with applicable standards and guidelines.
Assist with financial management activities, including budget development, expenditure tracking, forecasting, and reporting.
Serve as a liaison between research programs, regulatory offices, and partners, preparing briefings, reports, and communication materials for leadership.
Support acquisition planning, contractor oversight, and strategic initiatives, including performance tracking and process improvement efforts.
Prepare and deliver routine and ad hoc reports such as portfolio status, risk management, financial summaries, regulatory tracking, and annual program reports.

Benefits

Medical, Rx, Dental & Vision Insurance
Personal and Family Sick Time & Company Paid Holidays
Parental Leave
401(k) Retirement Plan
Group Term Life and Travel Assistance
Voluntary Life and AD&D Insurance
Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
Transit and Parking Commuter Benefits
Short-Term & Long-Term Disability
Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
Employee Referral Program
Corporate Sponsored Events & Community Outreach
Care.com annual membership
Employee Assistance Program
Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
Position may be eligible for a discretionary variable incentive bonus