Senior Clinical Trial Operations Specialist

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

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.