Lead Clinical Trials Program Manager

Socket.dev; Fairfax (VA); On-site; USD 170,000 - 200,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Job summary

Prometheus Federal Services (PFS) seeks an experienced Clinical Trials Program Manager to lead decentralized clinical trials (DCTs) for the Veterans Health Administration (VHA). You will oversee study coordination, regulatory submissions, and sponsor engagement, ensuring compliance and scalable decentralized research models.

The role emphasizes VA research experience, regulatory acumen, and collaboration across multidisciplinary teams to deliver high-quality, compliant clinical studies.

Qualifications

• Bachelor's degree required; Master's preferred.
• At least ten years of VA clinical research regulatory experience.
• Experience coordinating VA clinical research, oncology preferred.
• Ability to manage multiple complex priorities with high attention to detail.

Responsibilities

• Lead DCT data auditing, oversight, and study coordination for data integrity.
• Coordinate cross-functional meetings with FDA, sponsors, and VA groups.
• Develop and review SOPs, ORD materials, and CCRS reports.
• Negotiate study protocols, budgets, CDAs, SOWs, and CRADAs.
• Oversee regulatory submissions, patient screening, enrollment, and data entry.
• Ensure compliance with VA, FDA, and GCP standards.

Skills

Leadership

Regulatory knowledge

Stakeholder management

Communication

Education

Bachelor's degree

Master's degree or Nursing degree preferred

Tools

REDCap

Job description

Position Summary

Prometheus Federal Services (PFS) is a trusted partner to federal health agencies. We are exploring the addition of an experienced Clinical Trials Program Manager to provide leadership in planning, coordinating, and executing decentralized clinical trials (DCTs) in support of the Veterans Health Administration (VHA). The Clinical Trials SME will serve as a trusted advisor to government and industry stakeholders, overseeing complex clinical research activities, ensuring regulatory and ethical compliance, and advancing scalable decentralized research models. This role combines strategic oversight with hands-on study coordination, supporting protocol development, regulatory submissions, sponsor engagement, and day-to-day execution of clinical studies. The ideal candidate brings deep experience within VA research environments, strong regulatory acumen, and the ability to collaborate across multidisciplinary teams to deliver high-quality, compliant clinical research initiatives.

Essential Duties and Responsibilities

• Lead and execute Decentralized Clinical Trial (DCT) data auditing, oversight, and end-to-end study coordination to ensure data integrity and protocol adherence
• Direct and facilitate cross-functional meetings with internal teams, and external stakeholders, including FDA representatives, industry sponsors, and VA research groups, to advance DCT initiatives
• Author, review, and contribute to high-impact DCT documentation and deliverables, including VA Institutional Review Board (IRB) and Office of Research and Development (ORD) Standard Operating Procedures, training webinars, Centralized Clinical Research System (CCRS) reports, executive-level slide decks, and stakeholder engagement sessions
• Engage with sponsors to identify, evaluate, and onboard new DCT opportunities, translating research concepts into executable study designs
• Develop and negotiate study protocols and research agreements, including budgets, Confidential Disclosure Agreements (CDAs), Statements of Work (SOWs), Cooperative Research and Development Agreements (CRADAs), and Tele-Health Service Agreements (TSAs)for new studies
• Oversee and coordinate daily clinical research operations, including regulatory submissions, patient screening and enrollment, data entry, and comprehensive study management
• Support and guide patients through study participation activities, ensuring protocol compliance, accessibility, and participant engagement
• Plan, organize, and lead study team meetings, driving alignment, accountability, and progress toward key milestones
• Monitor study performance metrics and collaborate closely with Principal Investigator (PIs) to ensure timeliness, deliverables, and regulatory obligations are met
• Enforce adherence to federal, VA, and ethical research regulations, maintaining continuous compliance throughout the study lifecycle
• Maintain complete, accurate, and audit-ready research records in accordance with VA, FDA, and Good Clinical Practices (GCP) standards
• Synthesize and communicate research progress, risks, and findings to sponsors, investigators, and senior stakeholders

Minimum Qualifications

• Bachelor's degree required; Master's degree or Nursing degree preferred
• Demonstrate experience in VA clinical research coordination, with oncology research experience strongly preferred
• Minimum of ten (10) years of experience implementing and overseeing clinical research regulatory requirements
• Proven ability to manage multiple complex priorities with a high level of attention to detail and accuracy
• Exceptional organizational, interpersonal, and written and oral communication skills
• Experience working with electronic medical records (EMR/EHR) systems in clinical or research settings
• Ability to operate independently in a lead role while collaborating effectively within multidisciplinary teams
• Strong analytical and problem-solving skills, with the ability to resolve regulatory and operational challenges
• Hands-on experience with REDCap for clinical research data capture and management
• Ability to work in the U.S. indefinitely without sponsorship
• Ability to obtain a public trust

Compensation & Benefits

• PFS offers a benefits package that may include health, dental, and vision coverage; flexible spending accounts; disability and life insurance; a retirement plan; paid time off; and other programs to support employees and their families.

Learn more about PFS Benefits.

Salary Range $170,000 - $200,000

The posted salary range is the company’s good-faith estimate for this role. PFS benefits and compensation are determined by various factors, including, but not limited to, location; the individual's particular combination of education, knowledge, skills, competencies, and experience; as well as contract and organizational requirements.

Equal Employment Opportunity

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, parental status, national origin, age, disability, genetic information, political affiliation, military service, or other status protected by law.

Accommodations

PFS is committed to providing equal employment opportunities to all applicants. If you require a reasonable accommodation during the application or interview process, please contact us at [e-mail]. Reasonable accommodations are available to ensure applicants with disabilities have equal access to the hiring process, in accordance with the Americans with Disabilities Act (ADA) and applicable laws.

Workplace Health, Safety, and Compliance

This position may be subject to client-specific or government-mandated vaccination, health, or safety requirements, which may change over time.

Texting Privacy Policy and Information:

• Message type: Informational; you will receive text messages regarding your application and potentially regarding interview scheduling.
• No mobile information will be shared with third parties/affiliates for marketing/promotional purposes.
• Message frequency will vary depending on the application process.
• Msg & data rates may apply.
• Opt out at any time by texting "stop".