Clinical Trial Assistant
Lyell Immunopharma
$43 - $50 / hour
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Description
- 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
- BSc with a minimum of 7 years' experience
- MSc with a minimum of 4 years' 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
The incumbent will support the execution of assigned clinical study tasks.
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
KNOWLEDGE, SKILLS AND ABILITIES:
- Ability to continually develop an understanding of cross functional study delivery, CRO and other external vendor scope to deliver successful trial outcomes
- Ability to operate effectively in cross-functional, multi-disciplinary teams
- Demonstrated understanding of FDA regulations and ICH GCP guideline with an ability to successfully apply these to studies to drive effective, efficient and timely strategies
How this employer is doing
average
- Financial News
Typical pay for this role
$120,000
Typical range: $80,000 to $140,000
In the news
Lyell Immunopharma Reports Business Highlights and Financial Results for the Second Quarter 2026, GlobeNewswire
Pay for this role
$43 to $50 per hour
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