NeevSys is seeking a Clinical Trials Domain Subject Matter Expert with deep experience in clinical trials, clinical research enterprise systems, protocol metadata, accrual reporting, portfolio analysis, and clinical trial data-sharing requirements. The candidate will serve as the bridge between scientific stakeholders, business users, data teams, and IT implementation teams to ensure clinical trials requirements are accurately captured, translated, validated, and implemented in enterprise systems.
The ideal candidate will have prior experience supporting National Cancer Institute programs or similar federal biomedical research environments, especially systems that manage clinical research metadata, protocol information, accrual data, portfolio reporting, trial search capabilities, and regulatory or programmatic reporting.
Key Responsibilities
- Clinical Trials Domain Expertise – Provide subject matter expertise on clinical trials concepts, protocol lifecycle data, accrual reporting, trial status, study metadata, participating sites, disease areas, intervention data, eligibility criteria, and clinical research portfolio information.
- Clinical Research Enterprise Metadata – Support definition, review, mapping, and governance of clinical research metadata used across enterprise clinical trial systems, reporting platforms, data repositories, and trial search capabilities.
- Protocol and Accrual Reporting – Support requirements and validation for protocol reporting, patient accrual reporting, trial status tracking, study milestones, portfolio-level metrics, and regulatory or programmatic reporting needs.
- Portfolio Analysis Support – Analyze and interpret clinical trial portfolio data to support leadership reporting, scientific program analysis, performance monitoring, trial categorization, disease-area reporting, and operational decision-making.
- Patient and Clinician Trial Search Support – Define and validate data requirements that enable accurate patient- and clinician-facing clinical trial search, including disease terms, biomarkers, eligibility criteria, study location, recruitment status, intervention type, and trial summary information.
- Data Sharing and Interoperability – Support clinical trial data-sharing requirements, metadata standards, integration needs, terminology alignment, and exchange of clinical research data across enterprise systems and external reporting platforms.
- Business, Scientific, and IT Translation – Translate clinical, scientific, and regulatory requirements into clear business requirements, user stories, data definitions, acceptance criteria, workflow models, and system design inputs for IT teams.
- Stakeholder Engagement – Work directly with scientific program staff, clinical research stakeholders, data managers, business analysts, system owners, architects, developers, QA testers, and federal program managers to ensure shared understanding of requirements and outcomes.
- Requirements Validation and Testing Support – Review functional requirements, data mappings, reports, dashboards, and system outputs to ensure clinical accuracy, business alignment, and fitness for intended use.
- Process and Data Governance Support – Support standardization of clinical trial terms, data elements, reporting definitions, workflow rules, business rules, and quality checks across clinical research enterprise systems.
Required Qualifications
- 12+ years of experience supporting clinical trials, clinical research programs, biomedical research systems, clinical trial reporting, clinical data management, or related scientific IT initiatives.
- Strong understanding of clinical trial protocol data, accrual reporting, trial lifecycle status, study metadata, portfolio reporting, and clinical research operations.
- Experience translating clinical trial business needs into IT requirements, data requirements, user stories, business rules, workflows, and acceptance criteria.
- Experience working with scientific, clinical, business, and technical stakeholders in a cross-functional environment.
- Understanding of clinical trial data-sharing needs, metadata management, terminology alignment, and reporting requirements.
- Ability to review clinical trial system outputs, reports, dashboards, and data extracts for accuracy, completeness, and business relevance.
- Strong analytical, communication, facilitation, and documentation skills.
Preferred Qualifications
- Prior experience supporting NCI programs, systems, or stakeholders.
- Experience with cancer clinical trials, oncology research portfolios, or NCI clinical research enterprise systems.
- Familiarity with clinical trial search platforms, protocol reporting systems, accrual reporting systems, portfolio analytics, or clinical research data repositories.
- Experience with enterprise data governance, metadata standards, controlled vocabularies, data quality rules, or interoperability requirements.
- Experience supporting federal health, NIH, NCI, FDA, or biomedical research IT programs.
Education
- Bachelor’s degree in life sciences, clinical research, public health, biomedical informatics, healthcare administration, data science, information systems, or related field required.
- Master’s degree in public health, biomedical informatics, clinical research, life sciences, or related discipline preferred.
Preferred Certifications
- Clinical research certification such as CCRP, CCRA, or CCRC
- Good Clinical Practice certification
- NIH Human Subjects Protection certification
- Informatics, data governance, or business analysis certification preferred
Never miss an opportunity! Create an alert based on the job you applied for.
