Note: The job is a remote job and is open to candidates in USA. APV is a mission-driven technology company delivering AI/ML, data architecture, low-code/no-code, Agile DevSecOps, and cloud solutions to federal and state agencies. The Project Manager - FDA will lead delivery of an OCS Data Management and Data Quality Support task order, coordinating technical and operational workstreams, staffing, subcontractors, schedules, risks, issues, and government stakeholders.
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
Skills
- BS degree in Information Technology or related field. Relevant experience can be substituted for degree 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
- 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
- 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
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