Summit Therapeutics, Inc. · 6 hours ago
TMF Associate
Miami, FL
Full-time
Onsite
Entry Level
$35/hr - $45/hr
1+ years expSummit Therapeutics, Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing serious unmet medical needs. The TMF Associate will support the operational management of the Trial Master File (TMF) within Veeva Vault eTMF, ensuring TMF completeness, quality, and inspection readiness while collaborating with various teams.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Create and maintain site personnel records in Veeva, ensuring accuracy and alignment with study documentation
Manage user access requests within Veeva Vault, including onboarding, role changes, and offboarding, ensuring compliance with SOPs and access controls
Support creation, maintenance, and updates of the Electronic Document List (EDL) in collaboration with TMF and study teams
Update and maintain study and TMF milestones in Veeva Vault to support completeness and inspection readiness metrics
Add and maintain investigator sites within Veeva, including site status updates and configuration support
Perform routine quality checks to ensure accuracy and consistency of TMF system data
Provide day-to-day system support to TMF and Clinical Operations teams, including troubleshooting basic Veeva user or setup issues
Support TMF process improvements and standardization initiatives as assigned
All other duties as assigned
Qualification
Required
Bachelor's degree in life sciences, health sciences, or a related field preferred
1–3 years of experience in Clinical Operations, TMF, or clinical systems support
Hands-on experience with Veeva Vault eTMF required or strongly preferred
Understanding of TMF processes and ICH-GCP requirements
Strong attention to detail and ability to manage multiple tasks with accuracy
Demonstrated ability to work collaboratively across cross-functional teams
Strong written and verbal communication skills
Proficiency in Microsoft Office applications, particularly Excel
Benefits
Bonus
Stock
Benefits and/or other applicable variable compensation
Company
Summit Therapeutics, Inc.
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.79BKey Investors
CARB-XEurofarmaBiomedical Advanced Research and Development Authority (BARDA)
2025-10-21Post Ipo Equity· $500M
2024-09-11Post Ipo Equity· $235M
2024-06-03Post Ipo Equity· $200M
Leadership Team
Manmeet Soni
Chief Operating Officer and Chief Financial Officer
Recent News
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