Project Manager

POSITION SUMMARY

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

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