Senior Clinical Trial Manager # 4398

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 Menlo Park, 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.   

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

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, 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.

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.

GRAIL is an Equal Employment 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. GRAIL maintains a drug-free workplace.