Clinical Domain SME

Overview

On Site
Depends on Experience
Contract - Independent
Contract - W2
Contract - 12 Month(s)
No Travel Required

Skills

CTMS
Clinical Domain SME
SME
Clinical Domain
Clinical
Auditing
Clinical Trial Management System
Data Management
CDISC
SMO
SDTM
Workflow

Job Details

Clinical Domain SME

Location: NC

Position Summary

The Clinical Domain SME is a senior-level expert with comprehensive command of clinical development across pharma, biotech, medical devices, CROs, and SMOs. This role bridges deep functional knowledge spanning clinical data management, monitoring, site operations, and regulatory oversight with cutting-edge expertise in digital transformation, automation, analytics, and AI/GenAI.

You ll partner with executive and operational stakeholders to design future-state clinical operating models, enhance data integrity, improve execution quality, and accelerate time-to-market through intelligent technology adoption. Your work ensures alignment between clinical strategy, business needs, and digital innovation delivering measurable ROI.

Key Responsibilities

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

  • Lead optimization across core functional domains:

    • Clinical Data Management: eCRF strategy, EDC configuration, data review automation, reconciliation, database lock.

    • Monitoring & Oversight: RBQM strategy, remote monitoring, predictive risk signals.

    • Site/CRC Operations: eSource, scheduling, documentation workflows, protocol adherence, burden reduction.

    • PI Responsibilities: safety oversight, compliance governance, audit readiness.

  • Design and lead AI/GenAI transformation programs:

    • Intelligent protocol interpretation

    • Predictive enrollment and site/action insights

    • Automated documentation and data-quality workflows

    • Workflow digitization and process intelligence

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

  • Ensure compliance with global regulatory standards (ICH-Google Cloud Platform, GxP, ISO 14155, 21 CFR Part 11, GDPR).

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

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

Qualifications & Skills

  • Advanced degree preferred: PharmD, MS, RN, MD, PhD, MPH, or equivalent in Life Sciences/Healthcare.

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

  • Deep expertise in 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.

  • Proven transformation and consulting skills:

    • Value-case development, KPI benchmarking, ROI measurement

    • Change management and stakeholder alignment across geographies

    • Executive-level communication and influence

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.