Sr. Clinical Trial Associate

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life, increasing potential duration of life, and addressing serious unmet medical needs. Our team is driven by a mission to advance clinical studies in oncology, with multiple global Phase 3 trials underway, including:

• Non-small Cell Lung Cancer (NSCLC):
  • HARMONi: Phase 3 study evaluating ivonescimab combined with chemotherapy vs. placebo plus chemotherapy in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC (previously treated with a 3rd generation EGFR TKI).
  • HARMONi-3: Phase 3 study evaluating ivonescimab combined with chemotherapy vs. pembrolizumab combined with chemotherapy in first-line metastatic NSCLC.
  • HARMONi-7: Phase 3 study evaluating ivonescimab monotherapy vs. pembrolizumab monotherapy in first-line metastatic NSCLC.
• Colorectal Cancer (CRC):
  • HARMONi-GI3: Phase 3 study evaluating ivonescimab in combination with chemotherapy vs. bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy currently approved only by China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland.

About the Role

The Senior Clinical Trial Associate (Senior CTA) is an experienced clinical operations professional who supports the daily workflow of clinical operations activities. They provide robust administrative support to study teams, including managing meeting logistics, documentation, and vendor oversight.

Responsibilities

• Provides comprehensive administrative support to the clinical operations study team, including managing meeting logistics, creating agendas, and drafting meeting minutes with minimal oversight.
• Executes tasks assigned by the Clinical Operations Manager, such as study budget forecasting and tracking.
• Ensures accurate and timely documentation, including eTMF management, study contracts, and financial records in compliance with ICH-GCP, company policies, and regulatory requirements.
• Coordinates clinical operations activities across cross-functional teams, including contract management, vendor oversight, site start-up and activation, and protocol deviation tracking.
• Creates and maintains study-related materials, such as country and site binders, and tracks trial milestones.
• Ensures the eTMF is up-to-date and all essential documents are appropriately filed.
• Collaborates with CROs to ensure accurate data collection and entry into the CTMS and EDC.
• Attends and contributes to team meetings, taking detailed minutes.
• Supports clinical study management as delegated by Clinical Operations managers, including liaison with external vendors.
• Actively participates in process improvement initiatives to enhance clinical operations efficiency.
• Performs all other duties as assigned.

Requirements

• Bachelor’s degree in biological sciences, health sciences, or a medical field, or equivalent combination of education and experience.
• 4+ years of experience in a clinical study environment within a CRO or pharmaceutical company.
• Experience using Clinical Trial Management Systems (CTMS) and Clinical Trial Master File Systems (eTMF).
• Strong understanding of clinical drug development phases and clinical operation processes from start-up to close-out.
• Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices (GCP), and ICH guidelines.
• Ability to organize, prioritize tasks, identify and resolve issues efficiently, and manage multiple tasks effectively.
• Ability to work independently on routine assignments and collaborate effectively within a multi-disciplinary team.
• Outstanding interpersonal skills with strong oral and written communication abilities.
• High attention to detail, accuracy, and confidentiality.

Pay

$117,000 - $137,000 USD. Actual compensation is based on factors such as skill set, depth of experience, certifications, and work location. The total package may include bonus, stock, benefits, and other variable compensation.