Senior Clinical Research Program Leader

Goldbelt Apex LLC; Portsmouth (VA); On-site; USD 135,000 - 165,000; Full time

Job summary

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is seeking a Senior Clinical Research Program Manager to support the Naval Medical Center Portsmouth (NMCP) Clinical Investigation Department (CID) in Portsmouth, Virginia. This position serves as the Clinical Program Manager and Government-designated Key Personnel for the contract.

The Senior Clinical Research Program Manager provides scientific leadership, research regulatory expertise, personnel supervision, and overall

Qualifications

• Advanced knowledge of clinical, biomedical, health science, translational, or related scientific research.
• Strong knowledge of IRB- and/or IACUC-regulated research and associated protocol requirements.
• Knowledge of research protocol development, regulatory review, study execution, compliance monitoring, reporting, and dissemination.
• Knowledge of human-subject protection, research ethics, and regulatory compliance principles.
• Demonstrated ability to provide scientific and technical guidance to investigators, clinicians, scientists, research coordinators, and multidisciplinary research teams.
• Demonstrated ability to manage clinical/scientific research activities across the research lifecycle.
• Strong personnel leadership and supervisory skills in a multidisciplinary scientific or clinical environment.
• Ability to manage multiple research priorities, protocols, milestones, schedules, and deliverables simultaneously.

Responsibilities

• Provides overall leadership, management, and supervision of contractor personnel supporting NMCP clinical and scientific research activities.
• Serves as the contractor's primary day-to-day management representative and maintains authority to act for the contractor on operational contract matters.
• Provides continuity and sustainability for contractor-supported clinical and combat casualty care research programs.
• Serves as a research SME supporting investigators conducting IRB- and IACUC-regulated studies.
• Provides scientific and regulatory research guidance to NMCP departments and research personnel.
• Supports Government PIs and Clinical Protocol Developers in the formulation of research concepts, study objectives, and related activities, subject to Government approval.
• Supports research activities across the lifecycle from concept to dissemination.
• Maintains and monitors research regulatory documentation, approval requirements, and timelines.
• Monitors protocol deviations and corrective actions.
• Supports portfolio prioritization and alignment with NMCP mission.
• Tracks research data deliverables, reporting requirements, milestones, and schedules.
• Supervises multidisciplinary contractor personnel across protocol development, coordination, human-subject/animal research, bioengineering, simulation, and related activities.
• Ensures qualified contractor personnel are assigned and maintained across the program.
• Coordinates onboarding, CAC/access requirements, training, and personnel readiness.
• Monitors IRB/IACUC compliance and DoD/DHA requirements.
• Supports investigator-initiated human and animal research, regulatory submissions, and related research functions.
• Conducts research seminars and coordinates Government-approved training when authorized.
• Attends research conferences and supports development of scientific presentations as required.
• Coordinates with COR, NMCP CID leadership, Government PIs, and other stakeholders.
• Ensures contract reporting and tracking of PWS and deliverables.
• Supports implementation of the contractor Quality Control Plan and remediation of deficiencies.
• Supports transition-in/out activities and continuity of research operations.
• Performs other duties related to successful performance of the clinical research support program.

Skills

Clinical research leadership

IRB/IACUC knowledge

Regulatory compliance

Program management

Staff supervision

Stakeholder communication

Onsite coordination

Education

Post-doctoral/medical doctoral degree

Master’s degree in related field

Job description

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is seeking a Senior Clinical Research Program Manager to support the Naval Medical Center Portsmouth (NMCP) Clinical Investigation Department (CID) in Portsmouth, Virginia. This position serves as the Clinical Program Manager and Government-designated Key Personnel for the contract.

The Senior Clinical Research Program Manager provides scientific leadership, research regulatory expertise, personnel supervision, and overall