Sr. Clinical Trial Manager - Global

Redwood City, CA 94065

Posted: 11/21/2019 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 16783

Job Description


Job Summary
We are seeking a highly motivated individual to join the Clinical Operations team. This individual responsible for the overall execution of clinical study(ies) from initial concept through study completion, in accordance with all applicable regulations governing the conduct of clinical trials. Overall responsibilities may include the management of clinical operations activities and coordinating cross-functional efforts in the administration and progress of a clinical trial(s) in order to achieve trial objectives and corporate goals.
• Manages the implementation, on-time execution and conduct of clinical study(ies); including the development of study plan(s), key milestones, timelines, study costs, vendor selection as well as ensuring quality and compliance
• Provides effective study updates and tracking of progress to Senior Management
• Ability to identify potential risks that may impact the study(ies), e.g., study data, ethical conduct and adherence to ICH guidelines and provides risk mitigation solution
• Appropriately manage the various stages of study activities, e.g., start-up, treatment, maintenance, and close-out to ensure study is conducted on time and within budget
• Understands the data requirements of clinical study(ies) to ensure quality and integrity of data during collection, review, cleaning, and monitoring
• Performs duties with minimal supervision and has the ability to partner with other members of the team to complete deliverables on time
• Effective team player and exceptional written and interpersonal communication skills
• Demonstrated aptitude for strategic thinking skills
• Ability to manage delegated aspects of assigned clinical trials
• Ability to manage CROs and clinical study vendors
• Ability to influence and collaborate with cross-functional clinical study teams
• Strong planning and organizational skills
• Strong working knowledge of FDA & ICH/GCP regulations and guidelines
• Proficiency in MS office including Word, Excel, PowerPoint and other applications; demonstrated experience in technical writing
• Travel Requirements: internationally up to 25%
• BS/BA in Life Science or related discipline
• 5 years of experience in clinical and drug development
• Global clinical trial and CRO management experience in oncology
• Early-phase trial management experience preferred • Knowledge of ICH GCP guidelines and FDA regulations


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Jesse Ashworth

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