Sr. Clinical Trial Associate

About the role

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. Colorectal Cancer (CRC) 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.

Location: ONSITE - Miami, FL

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 as assigned by the Clinical Operations Manager, including 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, protocol deviation
• Creates and maintains study-related materials, such as country and site binders and tracks trial milestones
• Ensures the eTMF is being maintained up-to-date and all essential documents are appropriately filed in the eTMF
• Collaborates with CROs to ensure accurate data collection and entry into the CTMS and EDC
• Attends and contributes to team meetings, taking detailed meeting 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
• All other duties as assigned

Requirements

• Bachelor’s degree in biological sciences, health sciences or medical field, or equivalent combination of education and experience required
• 4+ years of experience in clinical study environment within CRO or Pharmaceutical company
• Experience using Clinical Trial Management Systems (CTMS) and Clinical Trial Master File Systems (eTMF) required
• Strong understanding of the phases of clinical drug development and clinical operation processes from start-up to close-out