Our goal is to detect cancer at its earliest and most treatable stage. We’re committed to reducing cancer-related deaths by promoting the adoption of innovative, safe, and effective technologies that can revolutionize cancer care.
As a healthcare company, we are at the forefront of developing new technologies for early cancer detection. Our team includes experts from various fields—scientists, engineers, and physicians—who are leveraging next-generation sequencing (NGS), large-scale clinical studies, and advanced computer and data science to tackle one of the most significant challenges in medicine.
GRAIL is based in Menlo Park, California, with additional offices in Washington, D.C., North Carolina, and the United Kingdom. We are backed by top global investors and companies in the pharmaceutical, technology, and healthcare sectors.
For more information, visit https://grail.com.
The Senior Clinical Data Manager (CDM) will oversee data management for one or more diagnostic product development studies, supporting GRAIL’s extensive clinical development efforts.
Responsibilities:
– Collaborate with GRAIL study teams to ensure clinical data is complete, accurate, and consistent.
– Handle study startup tasks, including protocol review, creating the Clinical Data Management Plan (CDMP), and setting up Electronic Data Capture (EDC) systems, while coordinating with Clinical Technology teams for system integration.
– Manage ongoing study activities such as team data reviews, documenting data decisions, issuing and resolving data queries.
– Use programming skills to generate data listings and dashboards as needed.
– Lead data lock processes, ensuring adherence to the CDMP by all team members.
– Maintain data integrity across all sources, including clinical data, bio-specimen storage data, and sequencing lab outputs.
– Keep documentation audit-ready and properly filed in the Trial Master File.
– Develop and review Data Transfer Plans with external data providers or collaborators.
– Support the Director of Clinical Data Management in developing data standards, procedural documents, and software initiatives.
Preferred Qualifications & Background:
– Minimum of 5 years of experience in clinical data management within the pharmaceutical, biotech, or diagnostics industries, especially in FDA-regulated settings. Proven experience with EDC systems and ensuring high data quality.
– Bachelor’s degree required; advanced degree preferred. Additional training in programming or analytics is highly desirable.
– Experience with IDE trials and device registries in the medical device or pharmaceutical sectors.
– Proven ability to lead medium to large clinical trials and manage multiple projects simultaneously.
– Familiarity with EDC systems and regulatory standards (e.g., ICH, GCP, HIPAA).
– Strong communication and organizational skills.
– Team-oriented with a history of achieving shared goals in cross-functional teams.
– Experience managing vendors and working with collaborators to meet contractual obligations.
– Knowledge of data visualization and analytics tools (e.g., Tableau).
– Programming experience in R or SAS is preferred.
– Prior experience working on the sponsor side is required.
– Background in molecular diagnostics is a plus.
– Experience developing clinical data management SOPs in collaboration with cross-functional teams.
The expected annual base salary for this full-time role in Menlo Park, CA is between $105,000 and $131,000. Actual compensation will depend on experience, skills, and location.
Depending on the role, employees may be eligible for an annual bonus or incentive plan tied to individual and company performance. We also offer a long-term incentive plan to support shared success.
GRAIL provides a comprehensive benefits package, including flexible time off, a 401(k) with company match, and a range of medical, dental, and vision plans, along with wellness programs.
GRAIL is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other legally protected status. We provide reasonable accommodations for individuals with disabilities throughout the hiring process and employment. Please contact us to request an accommodation. GRAIL maintains a drug-free workplace.
To apply for this job, please visit jobs.lever.co
