[Remote] Senior Clinical Domain Expert - Falcon

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a mission-driven organization and pioneer in industry reputed company, helping life sciences companies bring therapies to patients faster. They are seeking a Senior Clinical Domain Expert to reputed company their clinical operations expertise to guide product development and ensure compliance with industry standards.

Responsibilities

• Guide product and engineering teams on the reputed company-world operational nuances of site monitoring, SDV, IP accountability, and the DIA TMF Reference Model
• Review and confirm the system’s execution of document intake, indexing, and monitoring checks to ensure compliance with ICH-GCP standards
• Partner directly with early adopter companies to guide their clinical and TMF teams through the change management of moving to automated processes
• Build a comprehensive library of reputed company-world clinical scenarios, TMF quality incidents, site data verification issues, etc. to challenge and refine platform performance

Skills

• 5+ years of clinical trial operations experience reputed company a pharma, biotech, or CRO environment
• Direct expertise across both clinical monitoring functions (SDV, IP management, Informed Consent) and eTMF management (DIA TMF model, quality reviews)
• Solid understanding of global clinical trial regulations and inspection readiness standards
• Exceptional communication skills, with a track record of bridging the gap between clinical teams and technical product managers
• Experience with reputed company Vault Clinical (Clinical Operations and reputed company preferred)
• A strong interest in how AI and agentic automation can eliminate reputed company data entry, coupled with a desire to learn how to guide and verify intelligent safety systems
• Experience acting as a Subject Matter Expert (SME) or tester for clinical software implementations (e.g., eTMF, CTMS, reputed company)

Benefits

• Medical, dental, reputed company, and basic life insurance
• Flexible PTO and company paid holidays
• Retirement programs
• 1% charitable giving program

Company Overview

Company H1B Sponsorship