Senior Clinical Data Manager w/ R or SAS # 2508 ( Menlo Park or Remote)

Menlo Park, CA /
Bioinformatics and Data Science – Biostatistics and Clinical Data Management /
Full-Time
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 Senior Clinical Data Manager (CDM) will lead data management activities for multiple diagnostic product development studies in support of GRAIL’s robust clinical development pipeline.

You will:

    • Work closely with GRAIL study team members to ensure that clinical data captured is complete, consistent, and accurate. 
    • Perform study startup activities such as study protocol review, Clinical Data Management Plan (CDMP) development, and Electronic Data Capture (EDC) set-up, while collaborating with Clinical Technology staff to integrate with external systems.
    • Manage study conduct activities including facilitation of study team data review, documentation of data handling decisions, issuance of data queries and resolution of data discrepancies.
    • Utilize programming skills to create listings and dashboards as required by study team members.
    • Lead data locking efforts, ensuring that study team members have executed according to the CDMP.
    • Ensure that data integrity is maintained throughout the data lifecycle for sources including clinical data, external bio-specimen storage data, and data produced by ultra-deep ctDNA sequencing laboratories.
    • Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File.
    • Create/review the Data Transfer Plan with External Data Providers or collaborators.
    • Assist Senior Clinical Data Management and other GRAIL staff with developing and implementing data standards, controlled procedural documents, and software development efforts.

Your background and qualifications will include

    • 5+ years of industry experience required in clinical data management within the pharmaceutical, biotechnology, and/or diagnostics industry in an FDA-regulated environment, with a strong track record of EDC system implementation and collaboration with study teams to ensure data quality.
    • Bachelor’s degree required; advanced degree preferred. Additional coursework in programming, analytics, or related disciplines is strongly desired.
    • Experience working on IDE trials and device registries within the medical device and/or pharmaceutical industry.
    • Prior experience leading mid to large scale clinical trials and ability to support multiple projects at a given time. 
    • Experience working with EDC systems.
    • Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA).
    • Strong interpersonal communication (written and verbal) and organizational skills.
    • Excellent team player with demonstrated track record of success in a cross-functional team environment.
    • Consistent commitment to delivering on team goals with a sense of shared urgency.
    • Experience managing vendors and partnering with collaborators to deliver according to contracts and plans.
    • Familiarity with various data visualization, analytics, and reporting tools (e.g. tableau).
    • Experience programming in R, SAS is preferred.  
    • Prior experience working on the sponsor side is required.
    • Molecular diagnostics industry experience preferred.
    • Experience working on developing standard operating procedures for clinical data management in collaboration with cross functional teams.
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, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine and “Up to Date” with any recommended booster. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered; "Up to Date" means having timely received any COVID-19 vaccine booster(s) in accordance with CDC guidelines. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. 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 for consideration by GRAIL.