Note: The job is a remote job and is open to candidates in USA. Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. They are seeking a Senior Clinical Domain Expert to leverage their clinical operations expertise to guide product development and ensure compliance with industry standards.
Responsibilities
- Guide product and engineering teams on the real-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 real-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 within 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 Veeva Vault Clinical (Clinical Operations and EDC preferred)
- A strong interest in how AI and agentic automation can eliminate manual 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, EDC)
Benefits
- Medical, dental, vision, and basic life insurance
- Flexible PTO and company paid holidays
- Retirement programs
- 1% charitable giving program
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