Subject Matter Expert (SME) Clinical Research & AI Integration - Fulltime!!!

  • Posted 2 hours ago | Updated 2 hours ago

Overview

Remote
Depends on Experience
Full Time
Accepts corp to corp applications
Able to Provide Sponsorship

Skills

Subject Matter Expert (SME) Clinical Research & AI Integration

Job Details

As a Subject Matter Expert (SME) Clinical Research & AI Integration, you will play a pivotal role in bridging the gap between clinical operations and digital technology enablement, driving innovation across data standards, lab systems, and AI-powered clinical platforms.

Position Summary

The SME will be responsible for defining, designing, and guiding technology-driven solutions across Clinical Trials, Central Labs, Data Management, and Regulatory systems. The role involves collaborating with technical, business, and domain teams to conceptualize and deploy next-generation digital platforms that align with ICH-Google Cloud Platform, CDSCO, FDA, and EMA regulatory frameworks.

The candidate must possess deep clinical domain expertise, experience in system implementation (LIMS, CTMS, LTMS, Lab Matrix, ULTRA, QLIMS, etc.), and a clear understanding of how AI/ML, data analytics, and automation can optimize trial efficiency and compliance.

Education & Experience

  • Master s or Bachelor s degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field.
  • 10 12 years of total experience in clinical research, with a strong focus on IT system implementation and data standardization.
  • Prior experience with CROs, central labs, or technology partners supporting pharma clients preferred.
  • Certifications in CDISC, Google Cloud Platform, or Clinical Data Systems (e.g., Veeva, Medidata, Oracle) are advantageous

Key Responsibilities

  • Act as the clinical domain expert to define functional requirements for digital transformation programs across the clinical research ecosystem.
  • Collaborate with product and engineering teams to design and implement AI-driven clinical data platforms, Lab Information Systems (LIMS), and Trial Management Tools (CTMS, LTMS, etc.).
  • Drive process mapping, system validation, and integration across lab data, eClinical tools, and analytics systems.
  • Provide guidance on regulatory compliance (21 CFR Part 11, GDPR, NDCT Rules 2019) and ensure adherence to global data standards (CDISC, HL7, FHIR).
  • Lead cross-functional discussions with sponsors, CROs, and technology teams to define digital strategies for study setup, data management, and reporting.
  • Support proposal development, client presentations, and solution design workshops for business expansion in the Life Sciences vertical.
  • Define and maintain AI/ML enablement workflows for protocol digitization, data mapping, document automation, and RWE studies.
  • Support training, mentoring, and upskilling of internal programmers and analysts in clinical research processes and system compliance.
  • Contribute to building knowledge repositories, SOPs, and best practices for clinical technology delivery.

Mandatory Skills & Expertise

  • Deep domain knowledge of clinical trial operations, data management, and regulatory compliance.
  • Proven experience with clinical and lab systems (CTMS, LIMS, LTMS, etc).
  • Hands-on understanding of CDISC/CDASH/SDTM standards and data flow from EDC to submission.
  • Experience in clinical automation workflows, digital pathology, or AI-based data extraction.
  • Strong understanding of regulatory submissions, CTIS implementation, and protocol digitization (ICH M11).
  • Working knowledge of integration technologies (HL7, Corepoint, APIs) and data validation workflows.

________________________________________

Basic Technical Knowledge

  • Exposure to cloud platforms (AWS, Azure) and clinical data lakes.
  • Familiarity with RWE (Real-World Evidence) and SaMD (Software as a Medical Device) frameworks.
  • Understanding of clinical data visualization tools (Power BI, Tableau, Spotfire).
  • Awareness of AI/ML models for clinical data classification, mapping, and automation.
  • Basic experience in working with data pipelines and metadata-driven frameworks.

Soft Skills

  • Strong strategic and analytical thinking to bridge clinical and digital perspectives.
  • Excellent client-facing communication and presentation abilities.
  • Leadership and mentoring skills to guide cross-functional and technical teams.
  • Proactive problem solver with a focus on innovation and continuous improvement.
  • Ability to work across geographies and functions, managing multiple projects in parallel.
  • Commitment to quality, regulatory compliance, and business growth objectives.

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.

About Apexon