Senior Clinical Research Program Manager

Overview

Please note that this position is contingent upon the successful award of a contract currently under bid.

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.

Summary:

Please note that this position is contingent upon the successful award of a contract currently under bid.

Goldbelt 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 program management for contractor-supported clinical research activities at NMCP.

This is a senior clinical/scientific research leadership position requiring demonstrated experience with IRB- and/or IACUC-regulated research. The Program Manager serves as a research Subject Matter Expert (SME), provides continuity and sustainability across clinical and combat casualty care research programs, supervises multidisciplinary contractor research personnel, and maintains day-to-day authority for contractor task order performance.

The position supports research and scholarly activities involving the Combat Trauma Research Group (CTRG), Otolaryngology, Pediatrics, Nursing Research, Orthopedics, Women's Health, Emergency Medicine, Graduate Medical Education (GME) programs, the CID Animal Facility (ANFAC), and other NMCP research stakeholders.

The research portfolio encompasses human-subject and animal research, Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) protocols, Quality Improvement (QI), Quality Assurance (QA), exempt and non-human-subject research, and related scholarly activities.

This is a full-time, primarily onsite position at Naval Medical Center Portsmouth. Telework may be authorized in accordance with contract requirements and Government approval.

Responsibilities

Essential Job Functions:

• 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 Subject Matter Expert (SME) supporting investigators conducting IRB- and IACUC-regulated studies.
• Provides scientific and regulatory research guidance to NMCP departments and research personnel.
• Supports Government Principal Investigators (PIs) and Clinical Protocol Developers in the formulation of research concepts, conceptual frameworks, study objectives, research strategies, and related scientific activities, subject to final Government approval.
• Supports research activities across the lifecycle from research concept and protocol development through execution, regulatory compliance, data collection, reporting, presentation, publication, and dissemination.
• Maintains and monitors research regulatory documentation, approval requirements, and associated timelines.
• Monitors protocol deviations and associated corrective actions.
• Supports research portfolio prioritization and alignment with the NMCP mission.
• Tracks research data deliverables, reporting requirements, contract deliverables, milestones, and schedules.
• Supervises multidisciplinary contractor personnel supporting clinical protocol development, clinical research coordination, human-subject research, animal research, bioengineering/biomechanics, simulation, and related research activities.
• Ensures qualified contractor personnel are assigned and maintained across the program and monitors staffing vacancies and continuity risks.
• Coordinates contractor employee onboarding, Common Access Card (CAC) and access requirements, mandatory training, and personnel readiness.
• Maintains appropriate contractor supervision and the non-personal services relationship required for contractor personnel.
• Ensures contractor personnel comply with applicable IRB/IACUC protocols, research procedures, privacy requirements, and DoD/DHA requirements.
• Supports investigator-initiated human and animal research, regulatory submissions and amendments, informed-consent documentation, scientific review, IRB/IACUC coordination, research databases, specimen activities, study reporting, and related research functions.
• Conducts research seminars for contractor personnel and coordinates Government-approved research training when authorized.
• Attends research conferences and meetings and supports development of scientific presentations when required.
• Coordinates with the Contracting Officer's Representative (COR), Contracting Officer, NMCP CID leadership, Government PIs, and other authorized stakeholders.
• Ensures accurate and timely contract reporting and tracking of applicable PWS and contract deliverables.
• Supports implementation of the contractor Quality Control Plan and identification and correction of performance deficiencies.
• Supports transition-in and transition-out activities and continuity of research operations.
• Performs other duties directly related to successful performance of the clinical research support program.

Qualifications

Necessary Skills and Knowledge:

• 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.
• Ability to identify and address research, regulatory, staffing, schedule, and performance risks.
• Ability to communicate effectively with senior Government, clinical, scientific, contracting, and research stakeholders.
• Excellent scientific, technical, written, verbal, organizational, and interpersonal communication skills.

Minimum Qualifications:

• Candidates must meet one of the following education and experience combinations:
  • Post-doctoral or medical doctoral degree in a biological science, health science, physiology, veterinary medicine, or related field, with a minimum of 3 years of relevant research experience; or
  • Master's degree in a biological science, health science, physiology, veterinary medicine, or related field, with a minimum of 5 years of relevant research experience.
• For candidates qualifying through the Master's degree pathway:
  • Must possess at least 5 years of experience supporting IACUC- and/or IRB-approved research protocols from development through dissemination.
• Additional minimum requirements:
  • Demonstrated experience supporting IRB- and/or IACUC-regulated research.
  • Demonstrated experience with research protocol development, execution, compliance, and/or reporting.
  • Demonstrated ability to lead or supervise research personnel or multidisciplinary scientific teams.
  • Ability to work primarily onsite at Naval Medical Center Portsmouth in Portsmouth, Virginia.
  • Must be available during required Government coordination hours, including 0800-1630 Monday through Friday, except Federal holidays and Government administrative closures.
  • Must be able to satisfy applicable DoD/DHA personnel security, background investigation, CAC, privacy, HIPAA, training, and installation access requirements.
  • Must be able to provide a current resume/CV and signed Letter of Intent (LOI) for inclusion in the proposal as Key Personnel.

Preferred Qualifications:

• Doctoral-level degree (PhD, MD, DVM, or equivalent) in a biological, biomedical, health science, physiology, veterinary medicine, or closely related field.
• Experience supporting clinical research within the Department of Defense (DoD), Defense Health Agency (DHA), Military Health System (MHS), Department of Veterans Affairs (VA), or another federal healthcare/research organization.
• Previous experience within a Military Treatment Facility (MTF), academic medical center, clinical investigation program, or comparable complex research environment.
• Experience supporting investigator-initiated clinical research.
• Experience managing both human-subject and animal research portfolios.
• Experience with combat casualty care, trauma, emergency medicine, or military-relevant clinical research.
• Experience with clinical trials, clinical research operations, or clinical protocol development.
• Experience with research portfolio management and prioritization.
• Experience supporting scientific publications, presentations, or research dissemination.
• Experience with Graduate Medical Education (GME) research and scholarly activities.
• Experience supporting Quality Improvement (QI) and Quality Assurance (QA) research or scholarly projects.
• Experience with ClinicalTrials.gov, electronic IRB systems, or comparable research management platforms.
• Previous experience managing multidisciplinary personnel under a federal Government services contract.

Pay and Benefits

The salary range for this position is $135,000.00 to $165,000.00 annually

At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.