Senior Clinical Trial Associate

4+ years

$105,000 - $115,000 annually.

Menlo Park

10 March 3, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Clinical Trial Associate

Company: Summit Therapeutics
Location: Menlo Park, CA
Employment Type: Full-Time
Salary Range: $105,000 - $115,000 per year

Overview of Role:

Summit Therapeutics is seeking a Senior Clinical Trial Associate (Senior CTA) to support clinical operations by managing the daily workflow of clinical studies. The Senior CTA will provide administrative support to study teams, including meeting coordination, study document management, maintaining study trackers, and vendor oversight.

Key Responsibilities:

Provide administrative support to the clinical operations study team, including meeting logistics, agenda creation, and drafting meeting minutes.
Assist the Clinical Operations Manager with tasks such as study budget forecasting and tracking.
Ensure timely documentation and eTMF management in compliance with ICH-GCP, company policies, and regulatory requirements.
Coordinate clinical operations activities, including contract management, vendor oversight, site start-up, and activation.
Maintain study-related materials (e.g., country/site binders) and track trial milestones.
Ensure the eTMF is up to date and that all essential documents are appropriately filed.
Work with CROs to ensure accurate data collection in CTMS and EDC systems.
Attend and contribute to team meetings, taking detailed meeting minutes.
Support clinical study management by liaising with external vendors.
Participate in process improvement initiatives to enhance clinical operations efficiency.

Qualifications & Skills:

Bachelor's degree in biological sciences, health sciences, or a related field (or equivalent experience).
4+ years of experience in a clinical study environment within a CRO or pharmaceutical company.
Experience using Clinical Trial Management Systems (CTMS) and eTMF systems.
Strong understanding of clinical drug development phases and clinical operation processes from start-up to close-out.
Knowledge of FDA regulations, Good Clinical Practices (GCP), and ICH guidelines.
Ability to organize, prioritize, and manage multiple tasks effectively.
Strong interpersonal, oral, and written communication skills.
High attention to detail, accuracy, and confidentiality.

Compensation & Benefits:

Base Salary: $105,000 - $115,000 per year (actual compensation based on experience, location, and other factors).
Additional Benefits: Potential bonus, stock options, and other variable compensation.

Summit Therapeutics does not accept agency referrals without prior authorization.

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