Subject Matter Expert

Description:

BURGEON IT SERVICES is actively seeking a highly experienced Clinical SME (Subject Matter Expert) with a strong background in Clinical Research & Development (R&D) and Generative AI (GenAI) technologies. This hybrid role based in New York demands a professional who can work cross-functionally across global teams and act as a bridge between clinical operations and cutting-edge AI advancements.

The ideal candidate will possess over 10 years of industry experience with proven leadership in project management, clinical R&D processes, and AI tool integration, especially within life sciences organizations. The role also requires adeptness in strategic planning, stakeholder coordination, and the ability to work in a matrixed, fast-paced, and evolving environment.

Key Responsibilities:

• Serve as the clinical domain expert with in-depth knowledge of clinical research and regulatory frameworks

• Lead initiatives involving Generative AI applications, identifying automation opportunities in clinical workflows

• Translate business goals into technical project specifications that align with broader organizational objectives

• Manage project roadmaps, monitor delivery timelines, and ensure alignment with stakeholder expectations

• Collaborate with cross-functional teams including regulatory, IT, and clinical operations across geographies

• Maintain strong communication with global stakeholders, ensuring transparency and traceability

• Drive audit-readiness through rigorous documentation and compliance adherence

• Adapt to dynamic project scopes and deliver results amid ambiguity

Required Skills & Qualifications:

• Minimum 10 years of relevant experience in Clinical R&D

• Strong expertise in Generative AI tools, applications, and automation in the healthcare domain

• Exceptional project management and strategic planning skills

• Experience working in matrix environments and managing offshore/onshore teams

• Excellent stakeholder management across multiple time zones

• Comfortable managing evolving requirements and providing robust, scalable solutions

• Attention to detail in documentation, ensuring traceability and audit-compliance

Domain Expertise:

• Life Sciences, Clinical Operations, and AI-enabled digital transformation