Clinical Program Manager

Job Family:

Travel Required:

Clearance Required:

What You Will Do:

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.

What You Will Need:

• Masters 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.

What We Offer:

Guidehouse offers a comprehensive total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

• 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

• 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

About Guidehouse

Guidehouse is an Equal Opportunity EmployerProtected Veterans Individuals with Disabilities or any other basis protected by law ordinance or regulation.

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.

If you have visited our website for information about employment opportunities or to apply for a position and you require an accommodation please contact Guidehouse Recruiting at 1- or via email at . All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @ or . Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.

If any person or organization demands money related to a job opportunity with Guidehouse please report the matter to Guidehouses Ethics Hotline. If you want to check the validity of correspondence you have received please contact . Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicants dealings with unauthorized third parties.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.