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GRAIL

Senior Clinical Trial Manager # 4398

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Hybrid
Menlo Park, CA
Hybrid
Menlo Park, CA

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Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

GRAIL is headquartered in the bay area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.

For more information, please visit grail.com

The Sr. Clinical Trial Manager serves as a clinical operations leader, responsible for guiding the day-day execution of clinical trials, building and maintaining strong internal and external relationships, managing clinical sites, and partnering with cross-functional teams to ensure operational excellence and timely delivery of study milestones. This position will require a candidate to have experience with working in a fast paced environment, ability to work in ambiguity, proactive in seeking and utilizing the resources available to effectively problem solve, ability to be flexible and creative yet ensuring the clinical trial is executed within compliance of regulations and of the highest quality, and to be able to identify areas of improvement to drive efficiency within Clinical Operations.   

This role is based in Menlo Park, California, and will move to Sunnyvale, California in Fall 2026. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 40%, or 16 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 40% requirement for the site. At our Menlo Park campus, Tuesdays and Thursdays are the key days where we encourage on-site presence to engage in events and on-site activities.

Responsibilities:

  • 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
  • These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.

Required Qualifications:

  • 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

The expected, full-time, annual base pay scale for this position is $131,000K - $164,000K for Menlo Park, CA.  Actual base pay will consider skills, experience, and location.

This role may be eligible for other forms of compensation, including an annual bonus and/or incentives, subject to the terms of the applicable plans and Company discretion. This range reflects a good-faith estimate of the range that the Company reasonably expects to pay for the position upon hire; the actual compensation offered may vary depending on factors such as the candidate’s qualifications. Employees in this role are also eligible for GRAIL’s comprehensive and competitive benefits package, offered in accordance with our applicable plans and policies. This package currently includes flexible time-off or vacation; a 401(k) retirement plan with employer match; medical, dental, and vision coverage; and carefully selected mindfulness programs.

GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, , or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at [email protected] if you require an accommodation to apply for an open position.

GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!

HQ

GRAIL Menlo Park, California, USA Office

GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. We also have a number of employees who are working remotely. Our bay area office has a employees working in our labs, software engineering, clinical development and more.

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