GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

The Clinical Trial Manager has overall responsibility to support Clinical Operations. This will include supporting overall day-to-day execution of a clinical trial, building strong internal and external relationships, managing clinical sites, and collaborating with cross functional teams. 

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.

Duties & Responsibilities:

• Manages all clinical operational aspects of a clinical trial from site selection, start-up, enrollment, maintenance, and close-out
• Prepares and reviews study related plans and documents including protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans, and case report forms with minimal supervision
• Participates in identifying, selecting, and monitoring the performance of clinical sites
• Ensures proper site training and management, provides ongoing oversight of clinical site compliance with study plans, study protocol, SOPs, FDA regulations, ICH/GCP guidelines, and in accordance with all applicable regulations
• Participates in EDC set-up by contributing to case report form design, user acceptance testing, completion guideline development and other related activities
• Identifies any potential risks to the study timelines and/or conduct, proposes mitigations and implements mitigations with cross-functional team and manager support
• Monitors clinical data entry progress and follows up on incomplete data entry and/or outstanding queries
• Contributes to the development and management of site budgets and ensures invoice payment according to site payment terms
• Works cross functionally with other departments such as Legal, Data Management, Biospecimen Management, and Finance on all aspects of the clinical trial
• Provides oversight of regional monitors or contract research organizations (CRO)
• Establishes and maintains strong relationships and communication with sites and site staff
• Ensures Trial Master File (TMF) is current and maintained
• Provides guidance and mentorship to CPAs (Clinical Project Assistants)

Preferred 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 in either sponsor or CRO organizations, 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

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.