Senior Clinical Data Manager (Contract)

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 seeking a Staff Clinical Data Manager to join our innovative Clinical Data Management team and work collaboratively, with internal colleagues and external partners, to conduct large-scale studies generating clinical evidence for GRAIL’s products, ensuring data quality and integrity. The new hire will have an opportunity to support the real-world evidence generation program, managing clinical data from studies of our marketed product, or may support the pre-market clinical development studies.
You Will:

• Function as lead or supporting clinical data manager on large scale, complex clinical studies involving multiple collaborators
• Lead efforts involving cross-functional GRAIL study team members to ensure the completeness, consistency, and accuracy of the clinical data captured
• Perform study startup activities such as study protocol review, Clinical Data Management Plan (CDMP) development, and EDC set-up, which may involve collaborating with software engineering staff and integrating with external systems, or use of commercial EDC 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 to support study team activities
• 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 and bio-specimen data
• Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File
• Contribute to the development and implementation of data standards, SOPs, templates, and software

Your Background Will Include:

• 5+ years of industry experience, 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.
• Knowledge of clinical trials and medical device and/or drug development processes.
• Experience working on studies involving integration with Electronic Medical Records (EMRs) or other electronic data sources is a plus.
• Experience managing data for real-world evidence programs, registries, or other post-marketing studies is preferred.
• Knowledge of regulatory requirements and information governance frameworks (e.g. ICH GCP, Good Clinical Data Management Practices, 21CFR11, HIPAA).
• Good interpersonal communication (written and verbal) and organizational skills.
• Excellent team player with demonstrated 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.
• Prior experience programming with R, preferred.
• Prior experience with software systems development and integration, EDC programming / configuration, or APIs is desireable.
• Some local and international travel may be required.
• Medical Device 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.