GRAIL

Clinical Trial Manager

GRAIL

full-time

Posted on:

Origin:  • 🇺🇸 United States • California

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Salary

💰 $117,000 - $138,000 per year

Job Level

Mid-LevelSenior

Tech Stack

Google Cloud Platform

About the role

  • Support overall day-to-day execution of clinical trials, including site selection, start-up, enrollment, maintenance, and close-out.
  • Prepare and review study-related plans and documents including protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans, and case report forms.
  • Identify, select, and monitor performance of clinical sites; ensure site training and compliance with study plans, SOPs, FDA regulations, ICH/GCP.
  • Participate in EDC setup, case report form design, user acceptance testing, and related activities.
  • Identify risks to study timelines/conduct, propose and implement mitigations with cross-functional team support.
  • Monitor clinical data entry progress and follow up on incomplete data and queries.
  • Contribute to development and management of site budgets and ensure invoice payment.
  • Work cross-functionally with Legal, Clinical Data Management, Biospecimen Management, Finance, Clinical Compliance, Clinical Development, and Lab Operations.
  • Provide oversight of regional study monitors and/or CROs; facilitate external communication with site staff and pharmaceutical partners.
  • Ensure Trial Master File (TMF) is current and maintained; provide guidance and mentorship to Clinical Project Assistants (CPAs).

Requirements

  • Bachelor’s degree or equivalent in the life sciences or related field required.
  • Additional coursework in clinical trial planning and execution is strongly desired.
  • At least 5+ years of relevant experience in managing clinical trials at a sponsor company (pharma, biotech, or medical device).
  • Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable.
  • Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.
  • Working experience with an electronic data capture system, CTMS system, and eTMF system.
  • Experience working on Investigational Device Exemption (IDE) and Real World Evidence (RWE) studies (highly preferred).
  • Strong interpersonal communication (written and verbal), organizational and prioritization skills.
  • Able to work effectively under a fast-paced and changing environment.
  • Strong work ethic and demonstrated ability to deliver assignments on time.
  • Proficient with Microsoft Office and the Google suite of apps.