Project Manager - FDA

APV is a mission-driven technology company that delivers AI/ML, data, Agile DevSecOps, cloud, and consulting solutions to federal and state agencies. The Project Manager will lead delivery of an FDA data management and data quality support task order, coordinating technical and operational workstreams, staffing, schedules, risks, subcontractors, reporting, and stakeholder relationships.

Responsibilities:

• Serve as the principal day-to-day management interface with FDA and exercise authority to manage contractor personnel, subcontractors, schedules, and technical activities
• Develop, implement, and maintain the Project Management Plan, integrated project schedule, staffing model, communications approach, quality approach, configuration management, risk management, schedule management, and deliverable management
• Plan and facilitate contract kickoff, weekly status meetings, Agile sprint planning/reviews/retrospectives, technical working sessions, data-governance meetings, and ad hoc Government meetings
• Maintain the Assignment Log, Risk Register, Issue Log, action tracking, milestone tracking, and escalation process; perform root-cause and corrective-action management for significant issues
• Integrate operational work (data acquisition/validation/loading/curation) with modernization priorities so that software change does not interrupt production support
• Coordinate Analysis Studio/Data Central dependencies, release windows, migration or cutover activities, reviewer-facing change impacts, and cross-team responsibilities so platform changes do not disrupt regulatory-review support
• Prepare or approve Weekly Status Reports, Monthly Status Reports, Monthly Financial Reports, data-loading matrix updates, data-quality summaries, and business validation rule updates
• Maintain the Government-designated project repository and ensure current, complete, accurate, and internally consistent project artifacts
• Implement internal QA/QC and peer review before deliverable submission
• Manage staffing utilization, workload balancing, cross-training, backup coverage, and continuity of operations
• Lead transition-in sequencing, incumbent knowledge capture, onboarding, stakeholder interviews, transition risk management, and reporting
• Ensure proposal/contract staffing remains compliant with security, residency, confidentiality, and Government access requirements

Requirements:

• Knowledge and working experience with CDISC standards, including SDTM, ADaM, SEND, and ISS, as well as FDA business rules and FDA study data guidance
• Working experience managing IT system development projects
• 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
• BS degree in Information Technology or related field. Relevant experience can be substituted for degree requirements
• Strong technical literacy in regulatory study-data workflows and software/data-platform delivery sufficient to challenge assumptions and manage technical risk
• Agile delivery leadership and familiarity with FDA EPLC-style governance, integrated schedules, backlog management, release planning, and quality gates
• Metrics-driven program management using schedule adherence, load success, data-quality metrics, issue aging, throughput, staffing utilization, and customer/stakeholder feedback
• Familiarity with reviewer-facing analytical platforms and adoption/usage metrics, enabling the PM to connect operational performance, user feedback, release outcomes, and reviewer productivity without treating historical poster metrics as contractual targets
• Executive communication, conflict resolution, cross-contractor coordination, and ability to translate regulatory/mission priorities into executable work