Clinical Systems Implementation Specialist (Contingent)

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.