Project Manager - FDA

POSITION TITLE: Project Manager \- FDA 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 Leads overall delivery of the OCS Data Management and Data Quality Support task order, integrates technical and operational workstreams, manages staffing and subcontractors, controls schedule/risk/issues, and maintains effective coordination with the COR, Government Product Owner, OCS stakeholders, and other contractor teams. DUTIES 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. EDUCATION BS degree in Information Technology or related field. Relevant experience can be substituted for degree requirements. REQUIRED QUALIFICATIONS 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. PREFERRED QUALIFICATIONS 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. 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.