Project Manager

POSITION TITLE: Project Manager

LOCATION: Remote

CLEARANCE: Must be able to obtain a High-Risk Public Trust

COMPANY OVERVIEW

At APV, we’re more than a technology company — we’re a mission-driven powerhouse transforming organizations through advanced technology and human ingenuity. Our expertise spans AI/ML, data architecture, low-code/no-code development, Agile DevSecOps, and cloud services, delivering scalable and meaningful solutions.

In our Emerging Technology Lab, innovation drives progress. Our teams create intelligent chatbots, AI-powered assistants, robotic process automation (RPA), essay graders, and data analytics platforms. If you’re passionate about solving complex challenges and shaping the future, APV is the place for you. Since 2007, we’ve partnered with federal and state agencies to deliver IT, training, and consulting solutions that achieve mission-critical outcomes. Built on accountability, integrity, and quality, we go beyond expectations. With 70+ prime contracts and a proven record of client success, APV continues to grow — and we’re looking for exceptional talent to grow with us.

At APV, we Always Provide Value

POSITION SUMMARY

The Project Manager (PM) will provide overall leadership, coordination, and accountability for delivery of FDA/CDER optional shared services. The PM will serve as the primary management interface with the FDA COR and Project Manager and will integrate technical workstreams, staffing, schedule, quality, risk, reporting, knowledge management, and transition activities to ensure timely, consistent, and uninterrupted support to FDA reviewers.

DUTIES

• Lead day-to-day task order management across Clinical Services, Nonclinical Services, and optional shared-service activities; maintain clear accountability among technical leads and delivery staff.
• Develop and maintain the Project Management Plan, integrated schedule, work breakdown structure, work plan, milestones, quality assurance approach, and management processes for risk, change, configuration, communications, and requirements.
• Establish intake, prioritization, resource assignment, workload balancing, escalation, and monitoring processes so recurring and customized analytical requests meet agreed milestones and service expectations.
• Coordinate the project kickoff, recurring FDA status meetings, agendas, minutes, action items, decisions, and follow-up activities; communicate emerging risks, dependencies, staffing constraints, and corrective actions.
• Manage monthly status and financial reporting, task/CLIN performance, deliverable tracking, metrics, capacity utilization, and trend analysis; support FDA leadership with ad hoc data calls and management information.
• Oversee project and knowledge-management repositories, including controlled storage of datasets, scripts, logs, outputs, lessons learned, procedures, and program documentation in FDA-designated systems.
• Direct transition-in and transition-out activities, including onboarding, access/badging coordination, incumbent knowledge transfer, shadowing, documentation transfer, and maintenance of service continuity.
• Coordinate staffing and surge coverage across multidisciplinary personnel, including clinical and nonclinical SMEs, data standards specialists, statistical/data programmers, biostatisticians, analysts, and technical resources.

EDUCATION

• Bachelor’s degree in business, science, health, information technology, engineering, data/analytics, or a related field; advanced degree preferred

REQUIRED QUALIFICATIONS

• 7+ years of progressive project/program management experience, including leadership of multidisciplinary technical, data, scientific, or analytical service teams in a regulated or mission-critical environment.
• Demonstrated experience managing schedules, staffing, risk/issues, quality, reporting, stakeholder communications, deliverables, and fixed-price or performance-based work.
• Working knowledge of clinical/nonclinical data, regulatory review support, data standards, analytical programming, or scientific-computing environments sufficient to coordinate technical SMEs and communicate effectively with FDA stakeholders.
• Strong written and verbal skills
• Must be able to obtain and maintain a High-Risk Public Trust or equivalent federal client access. This role supports sensitive federal programs and involves elevated access to systems and data.
• Position requires the current ability to obtain and maintain required access without interruption in alignment with long-term program needs.
• Must be authorized to work in the United States without employer sponsorship now or in the future.

PREFERRED QUALIFICATIONS

• PMP or comparable certification; prior FDA/CDER, pharmaceutical, biotechnology, CRO, or Federal health experience; familiarity with OCS reviewer-support services, CDISC/SEND concepts, SAS/R/JMP/JMP Clinical, SharePoint, Jira or similar work-management tools, and transition of incumbent analytical services.

ABOUT APV

APV is an Equal Employment Opportunity employer. All qualified applicants are considered without regard to race, color, religion, sex, national origin, age, disability, genetic information, sexual orientation, gender identity, veteran status, or marital status.