Senior Clinical Data Manager 4239
Location: Menlo Park
Posted on: June 23, 2025
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Job Description:
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 Senior Clinical Data Manager (CDM) will lead
data management activities for one or multiple diagnostic product
development studies in support of GRAIL’s robust clinical
development pipeline. Responsibilities: 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 Director of Clinical Data
Management and other GRAIL staff with developing and implementing
data standards, controlled procedural documents, and software
development efforts. Preferred Qualifications & Background: 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. The expected, full-time, annual base pay scale for this
position is $105K - $131K 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.
Keywords: , San Bruno , Senior Clinical Data Manager 4239, Science, Research & Development , Menlo Park, California