Job Title: Project Manager I
Request ID: RFQ1826464
Project: CBER CASA-CV Support
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
Compensation -
Target Candidate Pay Rate: $70.12-$72.41 per hourPosition Summary
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.
Primary Responsibilities
- 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.
Required Qualifications
- 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.
Preferred Qualifications
- 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.
