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Clinical Trial Manager Or Senior Clinical Trial Manager

Company: Cymabay Therapeutics
Location: Newark
Posted on: March 13, 2023

Job Description:

POSITION SUMMARYAs a Senior Clinical Trial Manager (CTM) you will be in charge of driving study objectives through collaborative leadership. You will lead an international team of CymaBay team members as well as study site, CRO and vendor partners. What sets CymaBay's approach apart from others: We form strong partnerships within the organization and externally with our collaborators.Ideal candidates will have experience leading global phase 3 studies and managing full service CRO partnerships. Your voice will be heard across CymaBay through collaboration with biometrics, medical safety, regulatory and other teams.ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Lead full life cycle of study conduct from site selection and activation to enrollment, maintenance, and close-out
  • Collaborate with cross functional departments to meet company objectives on time and in budget
  • Identify risks to study timelines and conduct, propose mitigations and implement solutions with team and management support
  • Track study progress and communicate successes and risks through weekly reports
  • Represent the study at internal and external meetings: cross functional study meetings, Investigator Meetings, scientific conferences and 1:1 outreach to investigators
  • Manage and coordinate cross functional team dependencies
  • Monitor study quality metrics and identify areas for improvement: protocol deviations, clinical data entry, query resolution, and more
  • Primary CRO contact for study conduct
  • Work closely with CRO team to oversee clinical sites
  • Ensure compliance with protocol, overall clinical objectives, and regulatory requirements
  • Collaborate with team to prepare and lead review of study plans and documents
  • Participate in cross functional activities such as EDC and IWRS set-up
  • Mentor junior clinical operations team members
  • Complete other responsibilities as needed and agreed uponMINIMUM QUALIFICATIONS
    • Experience leading studies in a fast-paced environment
    • Success in CRO and vendor management
    • Excellent communication skills and ability to achieve milestones in a team environment
    • 6+ years clinical study experience with time at a sponsor company preferredEDUCATION, CERTIFICATES, LICENSES, REGISTRATIONS
      • Bachelor's degree or equivalent training and experience (i.e., technical degree) -The anticipated salary range for candidates who will work in Newark, California is $145,000 to $155,000. - The -final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. - CymaBay is a multi-state employer, and this salary range may not reflect positions that work in other states.Powered by JazzHR

Keywords: Cymabay Therapeutics, Newark , Clinical Trial Manager Or Senior Clinical Trial Manager, Executive , Newark, California

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