Staff Clinical Data Manager

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.

We are looking for a Staff Clinical Data Manager to execute data management activities for multiple clinical studies in support of GRAIL’s robust product development pipeline! This position will have the opportunity to work on large, multi-center clinical trials, and make significant contributions to the future of early cancer detection!
You Will:

• Contribute to GRAIL's clinical programs such as MSK and STRIVE studies from a clinical data management perspective.
• Work closely with GRAIL study team members and strategic partners 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 EDC set-up, while collaborating with Software Engineering staff to develop internal applications and 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 and appropriate tools to provide information as required by study team members.
• Lead data locking efforts, ensuring that study team members have executed according to the CDMP toward the goal of achieving analysis-ready datasets..
• Ensure that data integrity is maintained throughout the data lifecycle for sources including clinical data, and bio-specimen data.
• Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File.
• Collaborate with the CDM team and cross-functional GRAIL staff while developing and implementing data standards, authoring controlled procedural documents, and contributing to software development efforts.

Your Background Should Include:

• Bachelors degree required; advanced degree preferred. Additional coursework in programming, analytics, or related fields strongly desired.
• 5+ years of industry experience required, with a strong track record of EDC system implementation and collaboration with study teams to ensure data quality.
• Knowledge of clinical trials and medical device and/or drug development processes. Experience working on study start up, database locks, analysis timepoints and study closeout.
• Knowledge of regulatory requirements and information governance frameworks (e.g. ICH, GCP, HIPAA. GDPR).
• 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.
• Experience working on studies under the purview of the FDA and MHRA is a plus.
• Familiarity with various data visualization, analytics, and reporting tools.
• Prior experience programming with SAS, R or Python is a plus. Ability to work hands on with data using spreadsheet software required.
• Prior experience with software systems development and integration, EDC programming/configuration, or APIs is a plus.
• Some local and international travel may be required.
• Molecular diagnostics industry experience preferred.

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.