Clinical Trial Manager

5+ years

$135,000 to $155,000 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

Clinical Trial Manager
Summit Therapeutics Sub, Inc.
Menlo Park, CA

Salary: $135K - $155K / yr
Employment Type: Full-time
Posted: 28 days ago

Overview of Role:

A highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. This role oversees study startup, maintenance, and closeout while leading cross-functional teams, CROs, and vendors to ensure the successful execution of clinical trials.

Role and Responsibilities:

Oversee study scope, quality, timelines, and budget, ensuring objectives are met.
Develop and maintain professional relationships with key opinion leaders and clinical site staff.
Partner with CROs to ensure effective patient enrollment strategies and high-quality data collection.
Identify and manage study-related risks proactively.
Develop and manage essential clinical trial documents (protocols, CRFs, consent forms, etc.).
Review and manage study-related plans, processes, and agreements.
Review and approve site activation documents and monitoring reports.
Ensure compliance with Good Clinical Practices (GCP) and regulatory requirements.
Maintain a complete and inspection-ready Trial Master File (TMF).
Provide oversight and coaching for Clinical Trial Associates.
Perform other duties as assigned.

Experience, Education, and Skills:

Education: Bachelor’s degree in life sciences, nursing, pharmacy, or a related field.
Experience: 5+ years of clinical project management in international clinical trials (sponsor Pharma/Biotech).
Trial Expertise: Phase II and III experience required, oncology experience preferred.
Technical Knowledge: Strong understanding of drug development, ICH/GCP guidelines, and clinical trial processes.
Budgeting: Experience in budget forecasting and management.
Leadership: Proven ability to lead teams and oversee complex studies.
Communication: Strong interpersonal, decision-making, and problem-solving skills.
Travel: Ability to travel internationally (up to 20%).
Additional Skills: Experience in small organizations, strong planning and time management, and the ability to engage KOLs and site personnel effectively.

Compensation & Benefits:

The salary range for this role is $135,000 - $155,000 annually. Compensation is based on factors including experience, skills, certifications, and location. The total package may include bonuses, stock options, benefits, and other applicable variable compensation.

Note: Summit does not accept referrals from agencies without prior written authorization from the HR department.

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