Senior Clinical Domain Expert - Falcon
Summary
Senior Clinical Domain Expert designs and validates AI-driven automation for clinical trial workflows, focusing on Trial Master File management and CRA activities while ensuring compliance with ICH-GCP standards.
Job Title: Senior Clinical Domain Expert - Falcon
Job Location: Boston, MA
Job Location Type: Remote
Job Contract Type: Full time
Job Seniority Level:
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.
At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.
As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.
Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.
The Role
We are seeking a versatile, deeply experienced clinical operations professional to serve as our Senior Clinical Domain Expert for Veeva Falcon. In this role, you will bring your comprehensive knowledge of Trial Master File management and CRA activities to bear, advising our technical teams as they develop next-generation AI driven automation tools. You will act as the crucial "Voice of the Customer," verifying software outputs and working directly with early adopters to transform traditional clinical trial workflows.
What You'll Do
- Product Advisory & Workflow Mapping: Guide product and engineering teams on the real-world operational nuances of site monitoring, SDV, IP accountability, and the DIA TMF Reference Model
- Output Verification & Quality Gatekeeping: Review and confirm the system’s execution of document intake, indexing, and monitoring checks to ensure compliance with ICH-GCP standards
- Early Adopter Collaboration: Partner directly with early adopter companies to guide their clinical and TMF teams through the change management of moving to automated processes
- Scenario Curation: Build a comprehensive library of real-world clinical scenarios, TMF quality incidents, site data verification issues, etc. to challenge and refine platform performance
Requirements
- 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
Nice to Have
- Experience acting as a Subject Matter Expert (SME) or tester for clinical software implementations (e.g., eTMF, CTMS, EDC)
Interviewing with Veeva
We value your time and believe in a transparent hiring process. Here is the process you can expect.
- Follow the application process and submit your resume.
- Within 3 days, you will receive a link to a personality assessment administered by a third party.
- Once you complete the assessment, our team will review your full application package and follow up via email with our decision.
- If moving to the interview stage, the process is as follows:
- A conversation with the hiring manager
- A practical case exercise
- A final conversation with our group's Senior Leader.
- Once all interviews are complete, the manager will be in touch with a final decision.
Perks & Benefits
- Medical, dental, vision, and basic life insurance
- Flexible PTO and company paid holidays
- Retirement programs
- 1% charitable giving program
Compensation
- Base pay: $120,000 - $180,000
- The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.
Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at talent_accommodations@veeva.com.
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Originally posted on Himalayas