TMF Associate

Location: On-Site 4 days per week at our Menlo Park CA Princeton NJ or Miami FL locations

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.

Role and 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

Experience Education and Specialized Knowledge and Skills:

• Education: Bachelors degree in life sciences health sciences or a related field preferred
• Years of Experience: 13 years of experience in Clinical Operations TMF or clinical systems support
• Systems Expertise: Hands-on experience with Veeva Vault eTMF required or strongly preferred
• Knowledge and Skills:
  
  • 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
• Travel: 10%

The pay range for this role is $35/hr - $45/hr. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.