Clinical Domain SME || NC

Overview

Remote
Hybrid
Depends on Experience
Accepts corp to corp applications
Contract - Independent
Contract - W2
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

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.