Senior Manager, Centralized & Risk- Monitoring

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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. Summit’s 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.

Summit’s team is inspired to touch and help change lives through Summit’s 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.
• HARMONi-GI3:
  Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
• Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview

We are seeking a meticulous and detail-oriented Senior Manager, Centralized & Risk Based Monitoring to join our team. This is a critical role in overseeing the quality and integrity of clinical trial data, performing remote centralized monitoring, and ensuring compliance with regulatory requirements. This role will be responsible for identifying, assessing, and mitigating risks, ensuring optimal site performance, and collaborating with cross‑functional teams to improve clinical trial execution.

This position also involves identifying trends or discrepancies and collaborating with sites to support data cleaning, risk‑based monitoring, and the overall success of the clinical trial process.

Key Responsibilities:

• Central Monitoring:
  • Lead the implementation of centralized monitoring strategies across multiple clinical trials
  • Monitor and review clinical trial data across sites to ensure accuracy, completeness, and consistency with study protocols.
  • Perform real‑time data surveillance to identify outliers, trends, and potential issues that could impact data integrity.
  • Conduct risk‑based monitoring activities, such as assessing site performance, patient safety data, and identifying sites at risk of data discrepancies or protocol violations.
  • Utilize central monitoring tools and platforms (e.g., EDC, CTMS) to track study progress and ensure data consistency.
  • Support data query resolution by coordinating with site and CRO teams and ensuring timely data corrections.
• Clinical Data Review:
  • Review clinical data for trends, outliers, and inconsistencies that could indicate data issues or non‑compliance with the protocol.
  • Conduct data reviews in line with study timelines and regulatory requirements.
  • Evaluate subject data for completeness and accuracy to identify discrepancies early in the trial.
  • Collaborate with clinical research associates (CRAs), data managers, medical team, and other stakeholders to…