FEFA
Clinical Program Manager
FEFA, LLC seeks a Clinical Program Manager to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate. The OID Directorate conducts ongoing, laboratory-based surveillance of US military populations in unique environments to quantify and study the etiology of infectious illnesses. This position will support research on infectious pathogens affecting military personnel and advance studies related to pathogen biology, host-pathogen interactions, and disease transmission. This role will primarily be responsible for overseeing day-to-day project operations, ensuring contract compliance, managing resources, and serving as the primary point of contact for the client and internal teams. Compensation: $105,000.00-125,000.00 per year. Key Responsibilities: Lead the planning and implementation of project tasks, ensuring timely execution within scope and budget Interface regularly with the client, vendors, and internal stakeholders to ensure effective communication and project alignment Develop and maintain project documentation, schedules, and status reports Oversee onboarding and tasking of project personnel, ensuring role clarity and resource optimization Manage deliverables, track milestones, and proactively identify risks and mitigation strategies Provide regular updates to program leadership and ensure client satisfaction Ensure compliance with contract terms, federal regulations, and quality standards Supports Principal Investigators to develop protocols, write grants, meet regulatory requirements, and ensure scientific and operational success of research projects Project Management & Coordination Provides day-to-day supervision of department-based research staff, ensuring efficient coordination of clinical research projects. Manages the lifecycle of clinical research and bio surveillance studies, from protocol development through study implementation, data collection, and reporting. Collaborates with internal and external stakeholders, including researchers, clinicians, sponsors, and regulatory bodies, to ensure smooth project execution. Monitors project timelines, deliverables, and milestones, ensuring adherence to deadlines and budgets. Responsible for writing and reviewing monthly reports Budget Development & Management Develops, negotiates, and monitors project budgets related to funded research initiatives. Tracks and manages expenses, ensuring that projects remain within budget and align with the OID Directorate's financial objectives. Provides financial reports and updates to leadership, sponsors, and other key stakeholders as required. Regulatory Compliance & Quality Assurance Ensures that all clinical research projects comply with Institutional Review Board (IRB) requirements, Good Clinical Practice (GCP) guidelines, and relevant federal regulations. Monitors for quality assurance throughout the clinical research process, conducting regular reviews of data accuracy, regulatory compliance, and adherence to study protocols. Oversees the preparation and submission of regulatory documents, reports, and study-related correspondence. Staff Supervision & Development Supervises and mentors clinical research staff, providing guidance and support to ensure high performance and professional growth. Assigns responsibilities, oversees workload distribution, and conducts regular performance evaluations of clinical research team members. Facilitates training opportunities for staff to stay current with clinical research best practices, regulatory requirements, and relevant scientific advancements. Coordinate with public health, clinical, and operational partners to support timely data reporting and analysis. Direct and manage bio surveillance operations, integrating epidemiological data, syndromic surveillance, and lab results to identify and respond to emerging threats. Stakeholder Communication & Reporting Serves as the primary point of contact for sponsors, funding agencies, and external partners, ensuring timely communication and coordination throughout the project lifecycle. Prepares and presents project updates, progress reports, and final study findings to NHRC leadership and other stakeholders. Participates in the writing and editing of scientific publications, abstracts, and presentations related to clinical research findings. Develop and refine surveillance protocols, data-sharing agreements, and emergency response procedures. Team Leadership & Supervision: Supervise and mentor a multidisciplinary team of research coordinators, clinical staff, and bio surveillance analysts. Conduct performance evaluations, facilitate professional development, and support staff in meeting deliverables. Foster a culture of collaboration, accountability, and scientific integrity. Regulatory & Compliance: Ensure compliance with IRB requirements, DoD/NIH/FDA policies, and institutional procedures. Maintain accurate records and support audit readiness through comprehensive documentation. Manage adverse event reporting, protocol deviations, and other regulatory submissions. Strategic Planning & Communication: Develop project plans, manage timelines, and lead initiatives under tight deadlines and high-pressure environments. Support strategic planning for long-term research and surveillance priorities. Communicate progress and findings clearly to leadership, sponsors, collaborators, and external partners.
FEFA, LLC seeks a Clinical Program Manager to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate. The OID Directorate conducts ongoing, laboratory-based surveillance of US military populations in unique environments to quantify and study the etiology of infectious illnesses. This position will support research on infectious pathogens affecting military personnel and advance studies related to pathogen biology, host-pathogen interactions, and disease transmission. This role will primarily be responsible for overseeing day-to-day project operations, ensuring contract compliance, managing resources, and serving as the primary point of contact for the client and internal teams. Compensation: $105,000.00-125,000.00 per year. Key Responsibilities: Lead the planning and implementation of project tasks, ensuring timely execution within scope and budget Interface regularly with the client, vendors, and internal stakeholders to ensure effective communication and project alignment Develop and maintain project documentation, schedules, and status reports Oversee onboarding and tasking of project personnel, ensuring role clarity and resource optimization Manage deliverables, track milestones, and proactively identify risks and mitigation strategies Provide regular updates to program leadership and ensure client satisfaction Ensure compliance with contract terms, federal regulations, and quality standards Supports Principal Investigators to develop protocols, write grants, meet regulatory requirements, and ensure scientific and operational success of research projects Project Management & Coordination Provides day-to-day supervision of department-based research staff, ensuring efficient coordination of clinical research projects. Manages the lifecycle of clinical research and bio surveillance studies, from protocol development through study implementation, data collection, and reporting. Collaborates with internal and external stakeholders, including researchers, clinicians, sponsors, and regulatory bodies, to ensure smooth project execution. Monitors project timelines, deliverables, and milestones, ensuring adherence to deadlines and budgets. Responsible for writing and reviewing monthly reports Budget Development & Management Develops, negotiates, and monitors project budgets related to funded research initiatives. Tracks and manages expenses, ensuring that projects remain within budget and align with the OID Directorate's financial objectives. Provides financial reports and updates to leadership, sponsors, and other key stakeholders as required. Regulatory Compliance & Quality Assurance Ensures that all clinical research projects comply with Institutional Review Board (IRB) requirements, Good Clinical Practice (GCP) guidelines, and relevant federal regulations. Monitors for quality assurance throughout the clinical research process, conducting regular reviews of data accuracy, regulatory compliance, and adherence to study protocols. Oversees the preparation and submission of regulatory documents, reports, and study-related correspondence. Staff Supervision & Development Supervises and mentors clinical research staff, providing guidance and support to ensure high performance and professional growth. Assigns responsibilities, oversees workload distribution, and conducts regular performance evaluations of clinical research team members. Facilitates training opportunities for staff to stay current with clinical research best practices, regulatory requirements, and relevant scientific advancements. Coordinate with public health, clinical, and operational partners to support timely data reporting and analysis. Direct and manage bio surveillance operations, integrating epidemiological data, syndromic surveillance, and lab results to identify and respond to emerging threats. Stakeholder Communication & Reporting Serves as the primary point of contact for sponsors, funding agencies, and external partners, ensuring timely communication and coordination throughout the project lifecycle. Prepares and presents project updates, progress reports, and final study findings to NHRC leadership and other stakeholders. Participates in the writing and editing of scientific publications, abstracts, and presentations related to clinical research findings. Develop and refine surveillance protocols, data-sharing agreements, and emergency response procedures. Team Leadership & Supervision: Supervise and mentor a multidisciplinary team of research coordinators, clinical staff, and bio surveillance analysts. Conduct performance evaluations, facilitate professional development, and support staff in meeting deliverables. Foster a culture of collaboration, accountability, and scientific integrity. Regulatory & Compliance: Ensure compliance with IRB requirements, DoD/NIH/FDA policies, and institutional procedures. Maintain accurate records and support audit readiness through comprehensive documentation. Manage adverse event reporting, protocol deviations, and other regulatory submissions. Strategic Planning & Communication: Develop project plans, manage timelines, and lead initiatives under tight deadlines and high-pressure environments. Support strategic planning for long-term research and surveillance priorities. Communicate progress and findings clearly to leadership, sponsors, collaborators, and external partners.