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.

GRAIL is hiring a highly motivated Senior Clinical Study Manager, who will be responsible for providing comprehensive operational support for biopharma-sponsored clinical trials. The Senior Clinical Study Manager is responsible for developing, implementing, and monitoring clinical study execution plans from initial study intake through final project deliverables, and will drive process and procedure improvements for clinical trial operations support. This position can be located in the US or UK. 

You will:

• Act as Grail’s designated point of contact for all external stakeholders during a clinical trial regarding sample testing process, progress, and metrics 
• Partner with laboratory operations to ensure sample tracking and chain of custody is maintained from accessioning through data/report delivery 
• Identify relevant internal points of contact to resolve testing related queries, issues, and communicate to BioPharma on resolutions
• Support laboratory operations and personnel with guidance on sample return and destruction process for partner samples
• Identify internal cross functional teams that will support BioPharma audits, as well as internal process audits.
• Contribute to study close-out reports and communicate with the laboratory and biosample operations as appropriate to close GRAIL systems.
• Ensure compliance with GCP/ICH guidelines and regulations including review of all required essential documents necessary for study initiation to ensure audit ready study files through duration of study
• Support trial team in ensuring that study management, data collection and subsequent data transfers are in accordance with outlined specifications (DTA/DTS)
• Communicate process deviations identified by Quality and results of CAPAs from Quality to BioPharma partners. 
• Ensure study start-up activities are completed by cross-functional teams per BioPharma study requirements including:
• Development of clinical trial lab manuals and study specific test requisition forms and kits 
• Development of appropriate trial reports with the Software team 
• Ensure internal cross-functional team provides study start-up training materials (i.e. kits, training) as requested by BioPharma partners and external clinical trial sites
• Contribute to the development of study documents including but not limited to training slides, protocol, and reports
• Development of all trial-related SOPs relevant to GRAIL and agreement of these with external partners
• Serve as a liaison between BioPharma partners and internal teams for BioPharma clinical study collaborations, from study concept to final deliverable, including all day-to-day activities 
• Maintain documentation on key study contacts (internal and external).
• Communicate study updates provided by BioPharma partner to internal GRAIL teams: Clinical development, Product, Regulatory, Software, Compliance, Quality, Laboratory operations, and Bioinformatics functions as relevant 
• Involvement in the generation of project plans, especially those related to site management, monitoring and reporting
• Some travel to Menlo Park, CA or NC will be required.

Your background should include:

• Bachelor's Degree or equivalent in scientific field or equivalent combination of education, training, and experience
• At least 4 years of Clinical Operations experience in a professional life sciences environment
• Preferred: At least 2 years’ experience with oncology clinical trials in the biopharmaceutical or diagnostic industry, or in an academic center
• Excellent knowledge of applicable standards and regulations for clinical trials and laboratory conduct (CFR, ICH-GCP, Federal guidelines, GMP, GLP, ISO, etc.)
• Knowledge and experience working in MS Office Suite, Google Suite
• Proven history of successfully managing multiple concurrent initiatives and maintaining one's own workflow in a fast-paced, dynamic environment
• Demonstrated evidence of success working in a cross-functional environment; able to build strong relationships
• Strong organizational skills
• Ability to work well under pressure while maintaining a professional demeanor

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.