Subject Matter Expert (SME) - Microsoft Clinical Data Manager (IND)

Job Title : Subject Matter Expert (SME) - Microsoft Clinical Data Manager

Role Summary :

We are seeking a Subject Matter Expert (SME) to develop and maintain high-quality online course content for the Microsoft Professional Certificate in Clinical Data Management. The ideal candidate possesses deep expertise in clinical trial data cleaning, query management, CDISC/SDTM standards, healthcare data governance, and AI-assisted workflows, combined with a genuine passion for teaching and dynamic on-camera instruction.

Roles & Responsibilities :

• Discovery & Alignment: Validate Job Task Analysis (JTA) documents, Coursera In-Demand Topic (IDT) frameworks, and Program Architectures to ensure content directly aligns with industry standards for intermediate clinical data managers.
• Content Development & AI Augmentation: Create comprehensive instructional materials including case report form (CRF) review guides, data validation specs, and query escalation plans. Substantively enhance AI-generated drafts with first-hand clinical trial scenarios, lab/safety reconciliation, edit checks, and real practitioner context.
• Core Technical Instruction: Develop content across data cleaning in Power Query, clinical trial KPI reporting in Power BI, CDISC/SDTM metadata mapping, Azure Health Data Services ingestion, Purview governance, and Copilot prompt flows.
• Activity Testing & Lab Validation: Complete all learner activities end-to-end as a student across Microsoft Fabric, Azure Health Data Services, Power BI, Excel, Purview, Copilot, and Azure OpenAI to verify platform feasibility, UI accuracy, timing, and dataset integrity.
• Assessment Design & AI Audit: Design technical quizzes, data query drafting evaluations, and capstone projects. Formulate rubrics to evaluate data cleaning rigor, transformation precision, CDISC/SDTM literacy, and human-in-the-loop responsible AI auditing.
• Multimedia & Video Production: Appear on camera to lead instructional video modules and data walkthroughs, while building synthetic clinical trial datasets, query response templates, and Copilot prompt libraries for student labs.
• Governance & Safeguards: Enforce strict patient privacy and data isolation rules, ensure all case studies rely on anonymized or synthetic data, eliminate real PHI exposure, and integrate Microsoft Responsible AI healthcare compliance principles.
• Review, QA & Collaboration: Provide actionable in-line feedback and proposed fixes in shared documents, partnering closely with Instructional Designers, Clinical SMEs, and production teams while upholding Microsoft brand and AI governance guidelines.

Qualifications & Experience :

Required:

• 5–8 years in Clinical Data Management, Clinical Trial Operations, Health Analytics, or Bio-informatics, with 3+ years managing trial data cleaning and query lifecycles.
• 2+ years of hands-on experience incorporating modern data tools (Power BI, Power Query, Fabric) and AI workflows into clinical data processes.
• Demonstrated capability in CDISC/SDTM clinical data standards, query management, and healthcare data governance.
• Dynamic on-camera presentation capabilities to record instructional video modules with authentic conviction.
• Bachelor's degree in Clinical Research, Health Informatics, Life Sciences, Computer Science, Statistics, or related field (8+ years of relevant leadership accepted in lieu).

Preferred:

• Master's degree (MS in Clinical Research Administration, Health Informatics, Biostatistics, or Data Analytics).
• Background in corporate training, university instruction, or creating educational public video content.

Certification (Required/Preferred) :

• Certified Clinical Data Manager (CCDM) via SCDM (Preferred)
• Microsoft Certified: Power BI Data Analyst Associate (PL-300) / Fabric Analytics Engineer Associate (DP-600) (Preferred)