Clinical Trial Manager

Location
Newark, California
Posted
May 28, 2021
Required Education
Bachelors Degree
Position Type
Full time

At CymaBay, we are a clinical stage biopharmaceutical company committed to improving the lives of patients with liver and other chronic diseases by developing and providing access to innovative therapies. We are dedicated to enhancing the quality of healthcare by addressing the complex needs of patients, caregivers and communities and advancing medical knowledge.

CymaBay is expanding to support the re-initiation of clinical programs! We are looking for new team members to join and who support our mission.

Position Summary:

As a 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.

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
  • Be a strong representative for the study at internal and external meetings: cross functional study meetings, Investigator Meetings, scientific conferences and 1:1 outreach to investigators
  • Manage and coordinate the cross functional study team
  • Monitor study quality metrics and identify areas for improvement: protocol deviations, clinical data entry, query resolution, and more
  • Manage the CRO and be the primary point of contact
  • Manage multiple vendors (central lab, IxRS, eDiary, etc)
  • 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 upon

Qualifications:

  • Bachelor’s degree or equivalent training and experience (i.e., technical degree)
  • 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 drug company

More to Love:

An ambitious dedicated team with a strong and important company goal, new office in a beautiful biotech campus, offers competitive compensation and benefits. Reach out to us! We would love to share our journey and chat about the exciting things we are doing!