GRAIL

Senior Clinical Trial Manager

GRAIL

full-time

Posted on:

Location Type: Hybrid

Location: Menlo Park • California • 🇺🇸 United States

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Salary

💰 $131,000 - $164,000 per year

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Serves as the Clinical Operations Study Lead for assigned studies, providing strategic and operational leadership to ensure successful planning, execution, and delivery of clinical studies.
  • Supports and guides Clinical Trial Managers and Clinical Project Assistants ensuring alignment of study activities, promoting best practices, and driving a unified approach to achieve study objectives.
  • Acts as the primary point of contact for internal cross functional teams.
  • Leads site management and performance oversight, including ensuring proper training, fostering strong site relationships, and monitoring compliance with study protocols, plans, SOPs, GCP/ICH, and all applicable regulatory requirements.
  • Manages all clinical operational aspects of a clinical trial from site selection, start-up, enrollment, maintenance, and close-out.
  • Develops study related plans and documents, including informed consent forms, ensuring alignment with study objectives, regulatory requirements, and overall study strategy.
  • Collaborates on site identification and selection.
  • Participates in EDC set-up by contributing to case report form design, user acceptance testing, development of completion guidelines, and other related activities, supporting study requirements and data quality.
  • Oversees clinical data entry progress ensuring timely resolution of incomplete data and outstanding queries.
  • Contributes to the development and management of site budgets and ensures timely and accurate invoice payments in accordance with site payment terms.
  • Partners with cross functional stakeholders such as Clinical Data Management, Biospecimen Management, Finance, Clinical Compliance, Clinical Science, and Lab Operations to define study strategy, align operational plans, and proactively identify and mitigate risks to ensure successful execution.
  • Provides oversight of regional study monitors and/or contract research organizations (CRO) to ensure quality, compliance, and timely study execution while proactively addressing risk and performance issues.
  • Facilitate external communication with site staff and pharmaceutical partners (as applicable).
  • Ensures electronic Trial Master File (eTMF) is current and maintained.

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.
  • Ideal candidate will have at least 5 years of relevant experience in managing clinical trials, with at least 2 years experience in a Clinical Operations study lead role, at a sponsor company (pharma, biotech, or medical device) with a strong track record of successful trial initiation and execution.
  • 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.
  • 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 office automation tools, such as Microsoft Office and the Google suite of apps.
Benefits
  • Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan.
  • We also offer a long-term incentive plan to align company and colleague success over time.
  • GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical trial managementstudy planningsite managementdata quality assurancebudget managementregulatory complianceinformed consent documentationEDC set-upcase report form designclinical operations leadership
Soft skills
interpersonal communicationorganizational skillsprioritization skillsleadershipproblem-solvingadaptabilityteam collaborationstrategic thinkingrisk managementtime management
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