TMF Associate

Summit Therapeutics Sub • Miami, FL

1d • $35 - $45 • Onsite

About The Position

About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summits core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Overview of Role: The TMF Associate supports the day-to-day operational management of the Trial Master File (TMF) within Veeva Vault eTMF. This role is responsible for maintaining accurate system setup and study data to ensure TMF completeness, quality, and inspection readiness. Reporting into the TMF Director, the TMF Associate partners closely with TMF Managers, study teams, and CRO partners to support consistent TMF execution across Summits portfolio.

Requirements

• Bachelors degree in life sciences, health sciences, or a related field preferred
• 13 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level