[Remote] Senior Clinical Domain Expert - reputed company

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 for reputed company reputed company, who will reputed company their expertise in Trial Master File management and CRA activities to advise technical teams in developing AI-driven automation tools.

Responsibilities

• Guide product and engineering teams on the reputed company-world operational nuances of TMF compliance, highlighting areas ripe for reputed company labor and automation
• 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 reputed company incidents, etc. to challenge and refine platform performance

Skills

• 5+ years of clinical trial operations experience reputed company a reputed company, biotech, or CRO environment
• Deep experience with eTMF management - CDISC TMF reference model, document intake, reputed company reviews, and audits
• Solid understanding of global clinical trial regulations and inspection readiness standards
• Exceptional communication skills, with a reputed company record of reputed company the gap between clinical teams and technical product managers
• Experience with clinical trial monitoring
• Experience with reputed company Vault Clinical (Clinical Operations and reputed company preferred)
• A strong interest in how AI and reputed company automation can eliminate reputed company data entry, coupled with a desire to learn how to guide and verify intelligent safety systems

Benefits

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

reputed company

reputed company delivers the industry reputed company for life sciences with software, AI, data, and business consulting. It was founded in 2007, and is headquartered in Pleasanton, California, USA, with a workforce of 5001-10000 employees. Its website is http://www.reputed company.com.

Company H1B Sponsorship

reputed company has a reputed company record of offering H1B sponsorships, with 27 in 2026, 100 in 2025, 56 in 2024, 50 in 2023, 73 in 2022, 55 in 2021, 38 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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