Sr. Clinical Trial Associate

Summit Therapeutics, Inc.; Princeton (NJ); On-site; USD 117,000 - 137,000; Full time

Job summary

Summit Therapeutics Inc. in Princeton, NJ is seeking a Senior Clinical Trial Associate to support daily clinical operations, manage meeting logistics, agendas, minutes, and maintain study documents and trackers.

The role requires a B.S. in biological/health sciences, 4+ years CRO/pharma experience, CTMS and eTMF proficiency, and strong organizational and communication skills; you will collaborate across teams and ensure regulatory compliance.

Qualifications

• 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 FDA CFR, GCP, and ICH guidelines.
• Ability to organize, prioritize tasks and manage multiple tasks effectively.

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 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 trackers for trial milestones.
• Ensure the eTMF is up-to-date and all essential documents are filed appropriately.

Skills

Attention to detail

Communication skills

Organization

Cross-functional collaboration

Education

Bachelor’s degree in biological/health sciences

Tools

CTMS

eTMF

Job description

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.

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.

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.

SENIOR CLINICAL TRIAL ASSOCIATE

Overview Of Role

The Senior Clinical Trial Associate (Senior CTA) is an experienced clinical operations professional who is responsible for supporting the daily workflow of clinical operations activities. They will provide robust administrative support to study teams throughout the study. Key administrative activities include, but are not limited to, managing meeting invitations, creating agendas and meeting minutes, study document filing, maintaining study trackers, and oversight of the eTMF and vendors.

Role And Responsibilities

• Provides comprehensive administrative support to the clinical operations study team,including managing meeting logistics, creating agendas, and drafting meeting minutes, withminimal oversite
• Executes tasks as assigned by the Clinical Operations Manager, including study budgetforecasting and tracking
• Ensures accurate and timely documentation, including eTMF management, study contractsand financial records in compliance with ICH-GCP, company policies and regulatoryrequirements
• Coordinates clinical operations activities across cross-functional teams, including contractmanagement, vendor oversight, site start-up and activation, protocol deviation
• Creates and maintains study-related materials, such as country and site binders and trackstrial milestones
• Ensure the eTMF is being maintained up-to-date and all essential documents areappropriately filed in the eTMF
• Collaborates with CROs to ensure accurate data collection and entry into the CTMS andEDC
• 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 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
• 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 and work effectively within a team and within a multi-disciplinary environment.
• Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form
• Attention to detail, accuracy and confidentiality

This is the pay for this position

Pay Transparency

$117,000 - $137,000 USD

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 Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.