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Sr. Clinical Trial Manager

Company: Bayside Solutions
Location: Redwood City
Posted on: November 22, 2021

Job Description:

Sr. Clinical Trial ManagerRedwood City, CABayside Solutions has an exciting opportunity for a Sr. Clinical Trial Manager (Oncology) to join our client's growing team in Redwood City, CA. This individual is responsible for the overall execution of clinical studies from initial concept through study completion. Overall responsibilities may include the management of clinical operations activities and coordinating cross-functional efforts in the administration and progress of a clinical trial in order to achieve trial objectives and goals.Responsibilities:

  • Manages the implementation, on-time execution and conduct of clinical studies; 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 studies: study data, ethical conduct and adherence to ICH guidelines and provides risk mitigation solution
  • Appropriately manage the various stages of study activities: start-up, treatment, maintenance, and close-out to ensure study is conducted on time and within budget
  • Understands the data requirements of clinical studies 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 timeQualifications:
    • 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; 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

Keywords: Bayside Solutions, Redwood City , Sr. Clinical Trial Manager, Executive , Redwood City, California

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