Project Manager ,Federal Health IT & Study Data

Job Title -Mid-senior Project Manager Federal Health IT & Study Data

Experience: 8 12 Years

Employment Type: Full-Time (REMOTE)

**Domain:** Federal Health IT / FDA / NIH / Clinical & Nonclinical Study Data

Only USC/GC

Position Summary

We are seeking an experienced **Senior Project Manager** with 8 12 years of progressive experience managing complex IT, data, and modernization programs for **Federal health agencies**, preferably FDA, NIH, HHS, or related organizations.

The ideal candidate will combine strong federal project/program management capabilities with working knowledge of **clinical and nonclinical study data, regulatory review processes, scientific data standards, and health IT systems**. The Project Manager will lead multidisciplinary technical and scientific teams and serve as a primary interface with federal Contracting Officer's Representatives \(CORs\), program leadership, technical stakeholders, and partner organizations.

Key Responsibilities

- Lead end-to-end delivery of complex Federal health IT, scientific data, application modernization, cloud, analytics, and AI/data-management projects.

- Manage **scope, schedule, cost, resources, risks, quality, deliverables, dependencies, and contractual performance**.

- Serve as the primary day-to-day interface with Federal CORs, Government Program Managers, technical leads, scientific stakeholders, and contractor teams.

- Develop and maintain Project Management Plans, Integrated Master Schedules, risk/issue registers, staffing plans, status reports, action-item trackers, and performance dashboards.

- Manage Agile/Scrum delivery, including sprint planning, backlog management, release planning, demonstrations, retrospectives, and coordination across development, testing, security, infrastructure, and operations teams.

- Coordinate projects involving **clinical and nonclinical study data**, regulatory submissions, scientific review workflows, data ingestion, validation, transformation, analysis, and reporting.

- Work effectively with technical and scientific teams handling structured and unstructured study information, including protocols, study reports, datasets, regulatory documents, and supporting metadata.

- Support implementation and modernization of systems involving **CDISC standards**, including **SDTM, ADaM, SEND**, and related FDA study-data requirements.

- Coordinate requirements gathering and traceability across business, scientific, regulatory, security, and technical stakeholders.

- Support projects involving document processing, data extraction, analytics, AI/ML, NLP, generative/agentic AI, workflow automation, and scientific review tools.

- Manage system development and release activities across development, test, UAT, pre-production, and production environments.

- Coordinate Federal security and compliance activities, including **FISMA, NIST RMF/NIST SP 800-53, ATO, vulnerability remediation, POA&M, privacy, and Section 508** requirements.

- Ensure deliverables comply with agency standards, contractual requirements, quality-management processes, and established SLAs/KPIs.

- Identify project risks early and develop actionable mitigation and contingency strategies.

- Prepare and deliver executive-level status briefings, monthly reports, risk assessments, technical progress updates, and presentations to Government leadership.

- Manage subcontractors, vendors, and geographically distributed technical teams as required.

Required Qualifications

- **8 12 years of overall project/program management experience**, with significant experience supporting Federal Government IT or scientific/data programs.

- Demonstrated experience supporting **Federal health agencies such as FDA, NIH, HHS, CDC, CMS, or similar organizations**, with FDA and/or NIH experience strongly preferred.

- Proven experience managing complex IT systems, scientific applications, data platforms, cloud environments, or digital modernization initiatives.

- Working knowledge of **clinical and/or nonclinical study data and regulatory review processes**.

- Familiarity with FDA study data standards and terminology, including **CDISC, SDTM, ADaM, SEND**, and associated data-validation concepts.

- Understanding of clinical study protocols, clinical study reports, nonclinical/toxicology studies, regulatory submissions, and scientific review workflows.

- Strong understanding of **Agile/Scrum, SDLC, DevSecOps, requirements management, testing/UAT, release management, and production support**.

- Experience managing projects within Federal security and compliance environments, including FISMA, NIST controls, ATO/RMF, and Section 508.

- Demonstrated ability to manage multiple workstreams, competing priorities, technical dependencies, and aggressive Federal delivery schedules.

- Excellent written and verbal communication skills, including the ability to communicate effectively with Government executives, scientists, regulatory reviewers, engineers, developers, and cybersecurity teams.

- Strong experience developing Federal project documentation, executive briefings, status reports, risk registers, schedules, and performance metrics.

- Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, Health Informatics, Business, or a related discipline.

Preferred Qualifications

- **PMP certification strongly preferred.**

- Certified ScrumMaster \(CSM\), PMI-ACP, SAFe, or equivalent Agile certification.

- Direct project experience within **FDA CDER, CBER, CDRH, CVM, NCTR, or NIH Institutes/Centers**.

- Experience with FDA regulatory/scientific systems or platforms supporting clinical and nonclinical review.

- Familiarity with **FDA Study Data Technical Conformance Guide, Data Standards Catalog, validation rules, controlled terminology, and study-data submission processes**.

- Experience with cloud environments such as **AWS GovCloud, Azure Government, or other FedRAMP-authorized environments**.

- Experience managing AI/ML, NLP, Document AI, Generative AI, or agentic AI initiatives in regulated Federal health environments.

- Understanding of GxP, 21 CFR Part 11, data integrity, auditability, and traceability principles is desirable.