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Clinical Trial Manager

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5+ years
Not Disclosed
10 March 3, 2025
Job Description
Job Type: Full Time Education: BS 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

Location: South San Francisco, CA (Hybrid – 3 days in office per week)
Job Type: Contract (6 Months)

Position Overview:

We are seeking a Clinical Trial Manager to oversee the operational execution of Phase I and early-phase clinical trials. This role includes site activation, patient recruitment, study management, and vendor oversight. The CTM will collaborate with internal teams, CROs, and external partners to ensure successful study execution and contribute to the development of innovative treatments.

Key Responsibilities:

  • Support the execution of Phase I and early-phase clinical studies, including study set-up, budget tracking, and milestone management.
  • Assist with site feasibility, patient recruitment, and clinical study document preparation (protocols, ICFs, etc.).
  • Ensure compliance with ICH-GCP and regulatory guidelines.
  • Provide monitoring support and oversee vendors managing EDC, IRT, and specialty services.
  • Track study progress, maintain communication with senior management, investigators, and study personnel.

Qualifications:

  • Strong knowledge of US and global regulations (SOPs, ICH-GCP, FDA-CFR).
  • Proficiency in Microsoft Office, Smartsheet, eTMF, and clinical technologies.
  • Ability to manage clinical study documentation and risk management strategies.
  • Excellent organizational, time management, and multitasking skills.

Education & Experience:

  • B.S. or advanced degree in biological sciences or a related field.
  • Minimum 5 years of clinical trial management experience in pharma, biotech, or CRO environments.