Project Manager

Job Title: Project Manager I
Request ID: RFQ1826464
Project: CBER CASA-CV Support
Employment Status: Contingent upon contract award
Location: Washington, DC metropolitan area, including Rockville, Silver Spring, and Beltsville, Maryland
Work Arrangement: Local hybrid position. Remote work may be authorized by FDA, but the employee must be available for onsite meetings and activities when directed.
Schedule: Monday through Friday, generally 8:30 AM–5:00 PM Eastern Time
Travel: Local DC metropolitan travel may be required and is not separately reimbursable
Citizenship: Must be a United States citizen
Security Requirement: Must be able to obtain a Tier 2 Public Trust background determination and HSPD-12 PIV credential

Target Candidate Pay Rate: $70.12–$72.41 per hour

SMX Services & Consulting is seeking a Project Manager I to lead project, task-order, staffing, schedule, deliverable, risk, financial, and performance-management activities for the FDA CBER CASA-CV Support project.

The Project Manager will serve as the primary management interface between the contractor team and FDA stakeholders. The individual will coordinate technical activities involving clinical-data validation, Pinnacle 21 Enterprise, reporting, staffing, security onboarding, risk management, and annual cost-optimization requirements.

• Manage the scope, schedule, staffing, deliverables, meetings, risks, and performance of the task order.
• Serve as the primary contractor point of contact for the FDA Contracting Officer's Representative and program leadership.
• Plan and conduct the project kickoff meeting within ten business days after award.
• Prepare the kickoff presentation, meeting agenda, and meeting minutes.
• Submit kickoff meeting minutes within three business days after the meeting.
• Prepare weekly status reports for submission each Tuesday.
• Prepare monthly status reports by the 10th of each month.
• Prepare or coordinate monthly financial reports by the 5th of each month.
• Track accomplishments, planned activities, deliverables, risks, issues, action items, staffing, schedules, and dependencies.
• Maintain the project schedule and Project Management Plan.
• Maintain a Risk and Issue Log with assigned owners, mitigation actions, due dates, and resolution status.
• Coordinate and document project, technical, data-validation, and stakeholder meetings.
• Track action items and ensure timely closure.
• Maintain the project organization chart and identify key personnel.
• Track sprint completion, workload capacity, and velocity, where applicable.
• Manage staffing continuity throughout the project.
• Coordinate resumes and approvals for replacement personnel.
• Ensure new personnel are properly badged and have FDA network access before beginning billable work.
• Track completion of required FDA training, nondisclosure agreements, background investigations, and PIV processing.
• Develop and maintain the annual O&M Optimization Cost Reduction Plan.
• Identify initiatives designed to reduce O&M labor effort and cost by approximately 5% annually.
• Provide quarterly cost-reduction tracking and comparative performance data.
• Monitor contract burn rate, labor usage, deliverable status, and financial performance.
• Escalate risks or anticipated problems immediately rather than waiting for scheduled reports.
• Support quality control and ensure deliverables are accurate, complete, professional, and timely.
• Coordinate rare after-hours, release-window, or urgent-support activities when authorized by FDA.
• Ensure compliance with FDA security, CUI, records-management, privacy, and Section 508 requirements.

• United States citizenship.
• Ability to obtain a Tier 2 Public Trust determination and FDA PIV credential.
• At least five years of relevant experience in project management, project reporting, task monitoring, or related program-support activities.
• Experience managing technical or information-technology projects.
• Experience preparing project schedules, status reports, financial reports, risk registers, meeting minutes, and action-item logs.
• Experience coordinating multidisciplinary technical teams.
• Strong organizational and time-management skills.
• Ability to manage multiple recurring deliverables and strict deadlines.
• Strong written and verbal communication skills.
• Ability to communicate effectively with federal managers, technical personnel, analysts, and contracting officials.
• Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Project or comparable scheduling tools.

• Project Management Professional certification.
• Experience supporting FDA, HHS, or another federal civilian agency.
• Experience managing clinical-data, health-information, scientific, or regulatory projects.
• Experience supporting Pinnacle 21, CDISC, SDTM, ADaM, SEND, or comparable data-validation environments.
• Experience managing Firm-Fixed-Price federal contracts.
• Experience developing cost-reduction, process-automation, or operational-efficiency plans.
• Familiarity with Agile or sprint-based reporting.
• Familiarity with NIST, FISMA, CUI, HSPD-12, and federal information-security requirements.