Clinical Program Manager

What You Will Do

• 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.

What You Will Need

• 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.

What Would Be Nice To Have

• 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.

Pay

The annual salary range for this position is $85,000.00-$141,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.

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

This response is AI-generated, for reference only.