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Clinical Trial Manager

5+ years
$135,000 to $155,000 annually
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.