Job Title: Clinical Trial Manager (6-Month Contract)
Location:
South San Francisco, CA (Hybrid – 3 days in office per week)
Position Overview:
We are seeking a Clinical Trial Manager to support the operational execution of Phase I and early-phase clinical trials. This role will involve site activation, patient recruitment, study management, and vendor oversight. The Clinical Trial Manager will work closely with internal teams, CROs, and external partners to ensure the successful execution of clinical studies, contributing to innovative treatments aimed at improving patient outcomes.
Key Responsibilities:
Support the execution of Phase I and early-phase clinical studies, including study set-up, budget tracking, milestones, and timelines.
Assist with site feasibility, patient recruitment, and preparation of clinical study documents (protocols, informed consent forms, etc.) in compliance with ICH/GCP guidelines.
Provide monitoring support and help manage vendor relationships for systems such as EDC, IRT, and specialty services.
Track study progress, maintain communication with senior management, and build positive relationships with investigators and study personnel.
Professional Qualifications:
Strong knowledge of US and Global Regulations (SOPs, ICH-GCP, FDA-CFR).
Excellent time management, organizational, and multitasking skills.
Proficiency in Microsoft Office, Smartsheet, eTMF, and clinical technologies.
Experience in managing clinical study documentation and overseeing risk management strategies.
Education & Experience:
B.S. or advanced degree in biological sciences or a related discipline.
Minimum of 5 years of clinical trial management experience, ideally within pharma, biotech, or CRO environments.
Gujarat :
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