Clinical Trial Manager # 3850

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, , North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc.

NASDAQ : ILMN). For more information, please visit .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.

This is a hybrid role with a minimum of 2 days onsite at our Menlo Park, CA office.

Responsibilities will include but are not limited to :

• Managing all clinical operational aspects of a clinical trial from site selection, start-up, enrollment, maintenance, and close-out
• Preparing and review study related plans and documents including protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans, and case report forms with minimal supervision
• Participating in identifying, selecting, and monitoring the performance of clinical sites
• Ensuring 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
• Participating in EDC set-up by contributing to case report form design, user acceptance testing, completion guideline development and other related activitiesIdentifies any potential risks to the study timelines and / or conduct, proposes mitigations and implements mitigations with cross-functional team and manager support
• Monitoring clinical data entry progress and follows up on incomplete data entry and / or outstanding queries
• Contributing to the development and management of site budgets and ensures invoice payment according to site payment terms
• Working cross functionally with other departments such as Legal, Clinical Data Management, Bio-specimen Management, Finance, Clinical Compliance, Clinical Development, and Lab Operations on all aspects of the clinical trial
• Providing oversight of regional study monitors and / or contract research organizations (CRO)
• Facilitating external communication with site staff and pharmaceutical partners (as applicable).
• Ensuring Trial Master File (TMF) is current and maintained
• Providing guidance and mentorship to CPAs (Clinical Project Assistants)

Preferred Qualifications :

• Bachelor’s degree or equivalent in the life sciences or related field is required.
• Additional coursework in clinical trial planning and execution is strongly desired
• Ideal candidate will have 5 + years of relevant experience in managing clinical trials 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.
• 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 office automation tools, such as Microsoft Office and the Google suite of apps

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.In addition, 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.