Job Description
Westat is a leader in research, data collection and analysis, technical assistance, evaluation, and communications. Our evidence-based findings help clients in government and the private sector accelerate advancements in health, education, transportation, and social and economic policy. Our dedication to improving lives through research and our approach to projects grounded in investigative curiosity, statistical and data rigor, adaptive methods, and advanced technology are why clients find exceptional value in our work.
Job Summary
Westat is seeking an experienced Clinical Systems Implementation Specialist (Principal IT Associate) to support an NIH program focused on the implementation and optimization of clinical research systems. This role requires deep experience with COTS clinical applications, strong stakeholder engagement skills, and the ability to operate within regulated environments. The ideal candidate will bridge clinical, technical, and operational teams to ensure successful system configuration, deployment, and adoption. This position is contingent upon the award of the contract.
This position has a hybrid arrangement to work onsite at our Bethesda, MD office 3 days per week and 2 days per week from your home office.
Job Responsibilities
* Configure, implement, and support Commercial Off-The-Shelf (COTS) clinical software applications in support of clinical research and trial operations.
* Ensure system implementation and documentation align with regulatory frameworks, including GxP guidelines and 21 CFR Part 11 requirements.
* Lead and facilitate requirements gathering sessions, workshops, and stakeholder meetings to capture business and technical needs.
* Translate stakeholder requirements into functional specifications and system configurations.
* Develop and maintain comprehensive project documentation, including project timelines, requirements documentation, test cases, validation artifacts, and training materials.
* Support system testing, user acceptance testing (UAT), and training activities to ensure successful deployment and adoption.
* Collaborate with cross-functional teams including clinical staff, IT developers, QA teams, and program leadership.
* Analyze system performance and user feedback to recommend enhancements and continuous improvements.
Basic Qualifications
* Bachelor's degree in a relevant field (e.g., Health Informatics, Life Sciences, Information Systems, or related discipline).
* 12 plus years of experience to include 7 years of experience supporting clinical systems implementation, preferably within federal health or clinical research environments.
* Demonstrated familiarity with clinical research processes and regulatory frameworks, including GxP and 21 CFR Part 11.
* Hands-on experience configuring and implementing COTS clinical applications (e.g., EDC, CTMS, or similar platforms).
* Experience developing project artifacts such as timelines, requirements documentation, test cases, and training materials.
Preferred Qualifications
* Master's degree in Health Informatics, Life Sciences, Information Systems or a related field.
* Experience supporting NIH, HHS, or other federal health agencies.
* Familiarity with system validation processes in regulated environments (e.g., CSV, IQ/OQ/PQ).
* Experience with Agile or hybrid Agile/Waterfall delivery models.
* Knowledge of clinical data standards and interoperability frameworks (e.g., CDISC, FHIR).
* Experience supporting multi-system integrations across clinical and research platforms.
* Relevant certifications (e.g., PMP, Certified Clinical Research Professional (CCRP), Scrum Master).
* Experience facilitating requirements gathering sessions and stakeholder meetings across technical and non-technical audiences.
* Strong verbal and written communication skills, with the ability to translate complex technical concepts for diverse stakeholders.
* Demonstrated analytical and problem-solving skills in complex environments
Westat offers a well-rounded and comprehensive benefits program focused on wellness and work/life balance. Subject to plan requirements, employees may participate in:
- Employee Stock Ownership Plan
- 401(k) Retirement Plan
- Paid Parental Leave
- Vacation Leave (20 days per year)
- Sick Leave (9 days per)
- Holiday Leave (7 Government Holidays and 2 Floating Holidays)
- Professional Development
- Health Advocate
- Employee Assistance Program
- Travel Accident Insurance
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Short Term Disability Insurance
- Long Term Disability Insurance
- Life and AD&D Insurance
- Critical Illness Insurance
- Supplemental Life Insurance
- Flexible Spending Account
- Health Savings Account
Any offer of employment may be contingent upon receipt of acceptable results from a post-offer background screening, if required for the specific position, which may include, for example, identity verification, employment history, motor vehicle driving record history, and criminal or sexual offender records history. Any background screening results will be evaluated through an individualized assessment based on the individual's specific record and the duties and requirements of the position.
This opportunity will be posted for a minimum of 5 days and applications will be accepted on an ongoing basis.
Employment Eligibility: This is a U.S.-based position. Candidates must be authorized to work in the United States on a full-time basis. Westat does not offer employment-based visa sponsorship (including H-1B sponsorship) for this role. Depending on project requirements, some positions may require employees to meet specific residency criteria.
Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, creed, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, or any other protected status under applicable law. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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Westat
medical insurance, dental insurance, life insurance, vision insurance, flexible benefit account, parental leave, vacation time, sick time, short term disability, long term disability, 401(k), retirement plan
May 05, 2026