Clinical Domain SME || NC

Overview

Remote
Hybrid
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - 12 Month(s)
No Travel Required

Skills

Clinical Domain SME
SME
Generative Artificial Intelligence (AI)
ISO 9000
Life Sciences
Pharmaceutics
Pharmaceuticals
Remote Monitoring
Database
Data Quality
Data Management

Job Details

Job Title: Clinical Domain SME Life Sciences Consulting

Location: NC

Position Summary

Clinical Domain Subject Matter Expert (SME) to lead strategic transformation initiatives across the life sciences ecosystem. This senior-level role demands deep expertise in clinical development spanning pharmaceuticals, biotech, medical devices, CROs, and SMOs and combines functional leadership with digital innovation, automation, analytics, and AI/GenAI capabilities.

The SME will collaborate with executive and operational stakeholders to design future-state clinical operating models, enhance data integrity and patient outcomes, and accelerate time-to-market through intelligent technology adoption. This role ensures alignment between clinical strategy, business needs, and digital innovation to deliver measurable ROI.

Key Responsibilities
Clinical & Operational Expertise

  • Provide end-to-end clinical, operational, and regulatory guidance across all phases of drug and device development from protocol design to post-market evidence generation.

  • Ensure workflows and solutions comply with global regulatory standards: ICH-Google Cloud Platform, GxP, ISO 14155, 21 CFR Part 11, GDPR.

Functional Domain Optimization

  • Clinical Data Management:

    • eCRF strategy, EDC configuration, data review automation, reconciliation, database lock

  • Monitoring & Oversight:

    • RBQM strategy, remote monitoring workflows, predictive risk signal insights

  • Site/CRC Operations:

    • eSource enablement, scheduling, documentation flows, protocol adherence, burden reduction

  • PI Responsibilities:

    • Safety oversight, compliance governance, documentation accuracy, audit readiness

AI/GenAI Transformation

  • Lead initiatives in:

    • Intelligent protocol interpretation

    • Predictive enrollment and site/action insights

    • Automated documentation and data-quality assurance

    • Workflow digitization and process intelligence

Strategic Partnerships & Governance

  • Strengthen Sponsor CRO SMO relationships, outsourcing models, and delivery governance.

  • Translate clinical requirements into tech-enabled workflows and drive global user adoption.

  • Support business development through clinical solutioning, capability presentations, and thought leadership.

Qualifications & Skills
Experience

  • 8 18+ years in clinical operations, data management, monitoring, or PI/Site leadership within Pharma, Biotech, MedTech, CROs, or SMOs.

Technical Expertise

  • Deep understanding of clinical systems and data flows:

    • EDC (eCRF build, SDTM readiness)

    • IRT/RTSM (randomization, drug supply)

    • CTMS (study oversight, metrics)

    • eTMF/TMF (document governance)

    • RIM (regulatory lifecycle)

    • MDM & Data Hubs (integration, traceability)

    • Safety & PV systems (case management, signal detection)

    • Interoperability: CDISC SDTM/ADaM, HL7/FHIR

  • Strong command of digital trial capabilities:

    • DCT, eCOA/eConsent, wearables, eSource

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