Senior Clinical Data Manager

Overview

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 the bay area of 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.

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• 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.

• Requires 5+ years of industry experience 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.
• Experience working with EDC systems is required.
• Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA) is required.
• Prior experience working on the sponsor side is required.
• Experience programming in R, SAS is required.
• Strong interpersonal communication (written and verbal) and organizational skills required.

• Advanced degree preferred.
• Additional coursework in programming, analytics, or related disciplines is strongly preferred.
• Experience working on IDE trials and device registries within the medical device and/or pharmaceutical industry is preferred.
• Prior experience leading mid to large scale clinical trials and ability to support multiple projects at a given time is preferred.
• Excellent team player with demonstrated track record of success in a cross-functional team environment is preferred.
• Consistent commitment to delivering on team goals with a sense of shared urgency is preferred.
• Experience managing vendors and partnering with collaborators to deliver according to contracts and plans is preferred.
• Familiarity with various data visualization, analytics, and reporting tools (e.g. tableau) is preferred.
• Molecular diagnostics industry experience preferred.
• Experience working on developing standard operating procedures for clinical data management in collaboration with cross functional teams is preferred.

• Hours and days may vary depending on operational needs.
• Standing or sitting for long periods of time may be necessary.
• Some lifting (up to 25 pounds) may be necessary.
• Requires that a minimum of 40%, or 24…