eTMF Specialist, Clinical Operations
Join Us in Tackling Autoimmune Disease at Its Root
At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide.
When you join Vor, you’re not just working on a medicine. You’re part of a mission to redefine the future of autoimmune care.
Why Work at Vor?
Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases.
Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond.
Innovation: Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren’s syndrome.
Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies.
As an eTMF Specialist, your role is integral to managing and optimizing the electronic Trial Master File (eTMF) to ensure global clinical trials run seamlessly.
Key areas of responsibilities:
- Managing centralized clinical documentation activities for global trials.
- Uploading and conducting rigorous quality reviews of eTMF documents for inspection readiness.
- Ensuring compliance with ALCOA Plus principles in documentation.
- Collaborating with study teams to maintain high document quality, timeliness, and completeness.
- Acting as the primary point of contact for document management activities.
- Supporting clinical trials from initiation to close-out phases.
- Providing feedback on quality issues and proactively resolving documentation gaps.
Qualifications
To qualify for the eTMF Specialist position, candidates must meet the following criteria:
- A bachelor’s degree in Life Sciences, Business Administration, or equivalent experience. An advanced degree is a plus.
- 1–2 years of experience in clinical trial documentation management or a related field.
- Comprehensive knowledge of ICH/GCP guidelines and the drug development process.
- Familiarity with Clinical Trial Master File Systems, with Veeva Vault preferred experience.
- Proficiency in MS Office Suite, SharePoint, and clinical trial-enabling technologies.
Skills Required
- Strong organizational and time-management skills.
- Analytical and decision-making abilities to evaluate and prioritize tasks.
- Exceptional written and oral communication skills.
- Ability to work independently and manage multiple priorities.
- Adaptability and resilience in a dynamic environment.
- Demonstrated ability to collaborate and influence within a matrix structure.
- High attention to detail for maintaining quality and compliance in clinical documentation.
At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond.
As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Please visit our website at https://www.vorbio.com/ for more information.
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