Clinical Trial Manager (On-site, SSF)
South San Francisco, CA
Full Time
Manager/Supervisor
Role and Responsibilities
- Manages overall operation of one or more clinical trials, including project planning, budget, resource management and contract research organization management
- Manages clinical operational plan, and incorporates the study and scientific plan
- May develop study related documents and overall direction for the clinical sites to establish protocol development
- Ensures compliance with international Good Clinical Practices, IRBs/Ethics Committees and National Health Authority regulations
- Recommend and implement innovative process ideas to impact clinical trials management
- Oversee CRO clinical operations services and may act as the central coordinator of other functional group CRO services oversight
- May oversee clinical trial budgets and contracts for CROs, other operational vendors and clinical sites
- Oversee Corvus internal operational platforms including Clinical Trial Management System, Trial Master File and select components of a Quality Management System
- Acts as a cross functional liaison to ensure study plans align with clinical development strategies
- Collaborate with other relevant functional groups on study planning, protocol development and maintenance, and scientific abstracts and publications
- Exercises independent judgment in selecting methods, techniques and evaluation criteria for obtaining results
- Acts independently to determine methods and procedures on new or special assignments
- May supervise the operational responsibilities and professional development of other Clinical Operations staff
- This is an in-house position working from the Corvus office in South San Francisco 100% of time (Monday - Friday)
- Thorough knowledge of ICH Good Clinical Practices
- Bachelor’s degree or equivalent experience required
- Minimum 4 years of related experience required
- Excellent teamwork and collaboration skills
- Proficient with Microsoft Office.
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