Senior Clinical Trials Manager

4 weeks ago

Emeryville, California, United States Kyverna Therapeutics Full time

At Kyverna Therapeutics, we are committed to developing innovative cell therapies for patients suffering from autoimmune diseases. As a key member of our Clinical Operations team, the Senior Clinical Trials Manager will play a pivotal role in the successful execution of our clinical trials.

The ideal candidate will have a strong background in clinical trial management, with experience in managing all aspects of clinical trial conduct, including study start-up, enrollment, study conduct, and close-out. They will also have a working knowledge of current ICH GCP guidelines and applicable regulations.

The Senior Clinical Trials Manager will be responsible for leading a cross-functional study team, ensuring clinical trial activities and deliverables are completed on-time, within budget, and in accordance with quality standards. They will also be responsible for managing external vendors, overseeing the implementation and maintenance of the Trial Master File, and developing study documents and tools.

Key responsibilities will include:

  • Managing all components of a clinical trial, leading a cross-functional study team
  • Ensuring clinical trial activities and deliverables are completed on-time, within budget, and in accordance with quality standards
  • Participating in the identification, evaluation, selection, and oversight of clinical trial sites in collaboration with the Clinical Research Organization (CRO)
  • Partnering efficiently, effectively, and professionally with participating study sites to ensure smooth study conduct
  • Implementing strategic operational activities to ensure efficient study enrollment and high-quality monitoring activities at participating clinical sites
  • Reviewing invoices and tracking study budget according to the forecast, working closely with finance and clinical business operations
  • Managing external vendors with oversight of activities
  • Overseeing the implementation and maintenance of the Trial Master File for inspection readiness
  • Developing study documents and tools, including study, informed consent forms, project plans, budgets, study logs, templates, and other materials as needed
  • Collaborating with clinical team and vendors to develop study-specific documents, and maintenance of internal files
  • Providing study status updates and reports to senior management
  • Participating in ongoing study data reviews and data cleaning activities
  • Participating in RFP and vendor selection process, working closely with Clinical Operations leadership and Finance
  • Providing oversight of the CRO related to site initiation, interim monitoring, and close-out visits, as needed
  • Developing and delivering study training to investigators, site staff, and internal staff on select study processes
  • Participating in the preparation and follow-up of internal process audits, vendor, and study site quality audits, as well as regulatory authority inspections
  • Conducting internal meetings for assigned clinical trial(s)
  • Participating in external meetings (e.g., Investigator Meetings), conferences, and events
  • Training and mentoring new clinical trial staff with appropriate delegation and may be responsible for dotted-line management of team members
  • Escalating study issues/risks in a timely manner with solid communication skills
  • Developing or contributing to SOP development and best practices and facilitating their implementation, as needed

The ideal candidate will have a B.S. degree with a minimum of 6-8+ years of experience managing clinical trials in a biotech, pharmaceutical, and/or CRO environment. They will also have strong leadership, effective decision-making, and problem-solving skills, as well as a working knowledge of relevant GCPs and FDA/EMA regulations.

This is an exciting opportunity to join a patient-centered, clinical-stage biopharmaceutical company focused on developing innovative cell therapies for patients suffering from autoimmune diseases. If you are a motivated and experienced clinical trial manager looking for a new challenge, please submit your application.

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