Associate Director, Clinical Data Management

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 an Associate Director Clinical Data Management to plan and execute clinical data management activities for multiple clinical studies in support of GRAIL’s robust product development pipeline, with a focus on real-world evidence generation. This position will have the opportunity to work on large-scale clinical studies while collaborating with healthcare institutions and vendor partners, and making significant contributions to the future of early cancer detection!
You will:

• Function as a leader within the Clinical Data Management team and multidisciplinary study teams, planning, conducting, analyzing, and reporting results from large scale clinical studies involving the generation of real-world evidence.
• Lead efforts to ensure the completeness, consistency, and accuracy of the clinical data.
• Partner with contract research organizations and specialized real-world vendors to acquire and manage longitudinal clinical data.
• Development of strategy and implementation of innovative methods to capture regulatory-grade real-world data, ensuring integrity throughout the data lifecycle (e.g. acquisition, system integration, de-identification, transformation, mapping, natural language processing, technology enabled abstraction, variable derivation, etc.).
• Establish operational objectives and delegate assignments to direct reports and broader teams while mentoring and working alongside colleagues toward achievement of shared goals.
• Perform study startup activities such as study protocol development, Clinical Data Management Plan (CDMP) development, and EDC set-up, while collaborating with Software Engineering staff to develop and improve internal applications.
• 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.
• Use programming skills and appropriate tools to provide information as required by study team members.
• Lead data locking efforts, ensuring that study team members have carried out according to the CDMP toward the goal of achieving analysis-ready datasets.
• 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.
• Ensure that budgets, schedules, and performance requirements are established and met.

Your qualifications and background will include:

• Bachelors degree required; advanced degree preferred. Additional coursework in programming, analytics, data science, public health, or related fields is strongly desired.
• 10+ years of industry experience required, with a strong track record of EDC system implementation and collaboration with clinical study teams to ensure data quality.
• Experience managing data for real-world evidence programs, registries, or other post-marketing studies is preferred, and experience working on studies involving integration with Electronic Medical Records (EMRs) or other electronic data sources is a plus.
• 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 teammate 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 (e.g. Plateau, R Shiny).
• Prior experience programming with R, Python, or SAS 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 screening or 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.