Clinical Trial Assistant

lyellimmunopharma; Seattle (WA); On-site; USD 90,000 - 120,000; Full time

Job summary

Lyell Immunopharma is seeking a Clinical Trials Associate in Seattle to support trial execution and data coordination. You will work with CROs, site staff, and internal teams to meet study milestones and ensure data quality.

Ideal candidates have a life sciences background and hands-on trial monitoring experience, with familiarity with ICH GCP guidelines and TMF processes. The role offers a dynamic biotech environment in the U.S.

Qualifications

• Entry-level clinical studies support experience with Life Sciences exposure.
• Experience with field/site monitoring or sponsor in-house oncology drug development.
• Experience supporting early phase clinical studies and start-ups.

Responsibilities

• Conduct trial support activities and escalate issues with recommended solutions.
• Draft study plans, process documents and forms for trial execution; seek feedback from stakeholders.
• Collect and collate data from CRO/vendors and report to stakeholders; raise issues quickly.
• Track inputs and deliverables with Clinical Operations; coordinate with cross-functional partners for follow up.

Skills

Trial support

ICH GCP knowledge

Data collection & reporting

Vendor coordination

Education

BSc with 7+ years experience

MSc with 4+ years experience

Job description

Using living cells to treat - and sometimes even cure - cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. At Lyell, our goal is to change that. We are a clinical-stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for solid tumors based on our innovative technologies. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to defeat solid tumors, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency.

KEY ROLE AND RESPONSIBILITIES:

• Conducts trial support activities as assigned, escalates issues and recommends solutions to address concerns.
• Supports drafting of study plans, process documents and creates forms as needed for efficient trial execution; collaborates and seeks feedback from broader study team stakeholders to improve/optimize recommendations
• Collects and collates data from CRO/vendors, as assigned by Manager, Clinical Trials or Associate, Clinical Trials Management, reports data to stakeholders as needed, raises any issues to study lead quickly for timely resolution
• Tracks inputs and deliverables day-to-day in partnership with the Clinical Operations team; identifies ways to improve the way we track study progress, reaches out to cross-functional partners for follow up and pull through.
• Becomes subject matter expert in trial master file (TMF) requirements and conducts TMF review, reporting findings. Works with CRO and other vendors to support TMF maintenance by providing study documents when TMF resides with vendor.
• Learns and applies ICH GCP guidelines; stays current with evolving expectations and applies new protocols as required
• Tracks study expenses, as directed, tracks vendor or site invoices, routes invoices for

PREFERRED EDUCATION:

• BSc with a minimum of 7 years' experience
• MSc with a minimum of 4 years' experience

PREFERRED EXPERIENCE:

• Entry-level support experience of clinical studies with some Life Sciences industry experience
• Demonstrated experience with field/site monitoring, and/or sponsor in-house, and/or Oncology drug development
• Proven experience supporting clinical studies for early phase and start-ups