Summit Therapeutics, Inc.
Location
On‑site 4 days per week at our Princeton, NJ or Miami FL locations
About Summit Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life, extending life expectancy, and addressing unmet medical needs. We build a team of world‑class professionals who are passionate about this mission. Our core values are integrity, passion for excellence, purposeful urgency, collaboration, and a commitment to people.
Clinical Studies Summit’s clinical program includes multiple global Phase 3 studies covering various diseases, including:
Non‑Small Cell Lung Cancer (NSCLC) HARMONi: Evaluates ivonescimab + chemotherapy vs placebo + chemotherapy in EGFR‑mutated, locally advanced or metastatic non‑squamous NSCLC after 3rd generation EGFR TKI.
HARMONi‑3: Evaluates ivonescimab + chemotherapy vs pembrolizumab + chemotherapy in first‑line metastatic NSCLC.
HARMONi‑7: Evaluates ivonescimab monotherapy vs pembrolizumab monotherapy in first‑line metastatic NSCLC.
Colorectal Cancer (CRC) HARMONi‑GI3: Evaluates ivonescimab + chemotherapy vs bevacizumab + chemotherapy.
Overview of Role The Clinical Trial Associate (CTA) supports daily workflow of clinical operations activities, providing administrative support to study teams throughout the study. Key duties include managing meeting invitations, creating agendas and meeting minutes, filing study documents, maintaining study trackers, and overseeing the eTMF and vendors.
Role and Responsibilities
Provides administrative support to the clinical operations study team, including managing meeting logistics, creating agendas, and drafting meeting minutes.
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.
Creates and maintains study‑related materials, such as country and site binders, and tracks trial milestones.
Collaborates with CROs to ensure accurate data collection and entry into the CTMS and EDC.
Attend and contribute 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.
Experience, Education, and Specialized Knowledge and Skills
Bachelor’s degree in biological sciences, health sciences, medical field, or equivalent combination of education and experience.
At least 2 years of experience in a clinical study environment within a CRO or pharmaceutical company.
Strong understanding of the phases of clinical drug development and clinical operation processes from start‑up to close‑out.
Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines.
Ability to organize, prioritize tasks, identify and resolve issues efficiently; manage multiple tasks effectively and follow through on assigned tasks.
Ability to receive general instructions on new assignments and perform routine work independently; collaborate effectively within a multi‑disciplinary team.
Outstanding interpersonal skills and ability to communicate effectively in oral and written form.
Attention to detail, accuracy, and confidentiality.
Critical thinking, problem solving, ability to work independently.
Advanced knowledge of software applications (e.g., Word, Excel, PowerPoint, Adobe Reader) and database software (eTMF, EDC) to support operation of clinical trial databases and electronic filing methods.
Ability to work in a fast‑paced, demanding, and collaborative environment.
Demonstrate high ethical standards for honesty, truthfulness, and integrity.
Compensation The pay range for this role is $97,000 – $114,000 annually. Actual compensation packages are based on factors unique to each candidate, including skill set, depth of experience, certifications, and specific work location. The total compensation package may also include bonus, stock, benefits, and/or other applicable variable compensation.
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About Summit Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life, extending life expectancy, and addressing unmet medical needs. We build a team of world‑class professionals who are passionate about this mission. Our core values are integrity, passion for excellence, purposeful urgency, collaboration, and a commitment to people.
Clinical Studies Summit’s clinical program includes multiple global Phase 3 studies covering various diseases, including:
Non‑Small Cell Lung Cancer (NSCLC) HARMONi: Evaluates ivonescimab + chemotherapy vs placebo + chemotherapy in EGFR‑mutated, locally advanced or metastatic non‑squamous NSCLC after 3rd generation EGFR TKI.
HARMONi‑3: Evaluates ivonescimab + chemotherapy vs pembrolizumab + chemotherapy in first‑line metastatic NSCLC.
HARMONi‑7: Evaluates ivonescimab monotherapy vs pembrolizumab monotherapy in first‑line metastatic NSCLC.
Colorectal Cancer (CRC) HARMONi‑GI3: Evaluates ivonescimab + chemotherapy vs bevacizumab + chemotherapy.
Overview of Role The Clinical Trial Associate (CTA) supports daily workflow of clinical operations activities, providing administrative support to study teams throughout the study. Key duties include managing meeting invitations, creating agendas and meeting minutes, filing study documents, maintaining study trackers, and overseeing the eTMF and vendors.
Role and Responsibilities
Provides administrative support to the clinical operations study team, including managing meeting logistics, creating agendas, and drafting meeting minutes.
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.
Creates and maintains study‑related materials, such as country and site binders, and tracks trial milestones.
Collaborates with CROs to ensure accurate data collection and entry into the CTMS and EDC.
Attend and contribute 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.
Experience, Education, and Specialized Knowledge and Skills
Bachelor’s degree in biological sciences, health sciences, medical field, or equivalent combination of education and experience.
At least 2 years of experience in a clinical study environment within a CRO or pharmaceutical company.
Strong understanding of the phases of clinical drug development and clinical operation processes from start‑up to close‑out.
Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines.
Ability to organize, prioritize tasks, identify and resolve issues efficiently; manage multiple tasks effectively and follow through on assigned tasks.
Ability to receive general instructions on new assignments and perform routine work independently; collaborate effectively within a multi‑disciplinary team.
Outstanding interpersonal skills and ability to communicate effectively in oral and written form.
Attention to detail, accuracy, and confidentiality.
Critical thinking, problem solving, ability to work independently.
Advanced knowledge of software applications (e.g., Word, Excel, PowerPoint, Adobe Reader) and database software (eTMF, EDC) to support operation of clinical trial databases and electronic filing methods.
Ability to work in a fast‑paced, demanding, and collaborative environment.
Demonstrate high ethical standards for honesty, truthfulness, and integrity.
Compensation The pay range for this role is $97,000 – $114,000 annually. Actual compensation packages are based on factors unique to each candidate, including skill set, depth of experience, certifications, and specific work location. The total compensation package may also include bonus, stock, benefits, and/or other applicable variable compensation.
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