Senior Clinical Trial Manager

Overview

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.

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• 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.

• 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…