Associate, Clinical Trial Management

Lyell Immunopharma•Seattle, WA

About The Position

The Associate, Clinical Trial Management supports clinical trial execution under the guidance of the Director or Associate Director of Clinical Operations and/or a Senior Clinical Trial Manager. The role conducts assigned trial tasks, develops practical plans and processes, oversees defined CRO deliverables, tracks study activity and expenses, and escalates issues with recommendations for resolution. It also supports trial master file (TMF) maintenance and applies evolving ICH GCP expectations to trial management. Lyell is a clinical-stage company developing next-generation CAR T-cell therapies for solid tumors and hematologic malignancies. Its integrated capabilities span technology discovery, translation of science into therapies, manufacturing, and clinical evaluation. The company describes its culture as based on Science, Respect, Collaboration, and Courage, and is committed to an open, diverse, and inclusive workplace.

Requirements

Experience in oncology clinical trial programs is required.
At least 2 years of experience supporting clinical studies.
Ability to collaborate with and manage CROs and other external vendors to achieve successful trial outcomes.
Ability to operate effectively in cross-functional, multidisciplinary teams.
Understanding of FDA regulations and ICH GCP guidelines, with the ability to apply them to clinical studies.
Preferred: Bachelor of Science in Life Sciences or a related discipline.
Preferred: Minimum 4 years of experience.

Nice To Haves

Early-phase clinical trial and study start-up experience.
Field or site monitoring experience.
Sponsor in-house experience.
Oncology drug development experience.

Responsibilities

Conduct assigned tasks related to clinical trials and escalate issues, recommending solutions to address concerns.
Develop tactical plans, detailed process steps, and forms to support efficient trial execution; collaborate with study team stakeholders and incorporate their feedback to improve recommendations.
Oversee defined tasks with CRO partners and ensure deliverables are completed on time and to an appropriate quality standard; raise issues to the CTM or Senior CTM and recommend ways to address concerns.
Track study inputs and deliverables day to day with the Clinical Operations team; identify improvements to study-progress tracking and follow up with cross-functional partners.
Collaborate effectively and serve as a mentor and subject matter expert for more junior clinical team members.
Support TMF maintenance by filing study and vendor documents promptly, assisting with TMF reviews, and reporting findings to the CTM.
Continue learning and applying ICH GCP guidelines, stay current with evolving expectations, apply new protocols as required, and recommend processes and procedures that support effective trial management.
Track study expenses as directed by the Associate Director or Senior CTM, monitor vendor invoices, and route invoices for approval.