Senior Clinical Data Manager (RWE/RWD) # 4426

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. For more information, please visit grail.com The Senior Clinical Data Manager (CDM) will lead data management activities for one or multiple diagnostic product development studies in support of GRAIL’s robust clinical development pipeline. This role is based in Menlo Park, California, and will move to Sunnyvale, California in Fall 2026. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 40%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 40% requirement for the site. At our Menlo Park campus, Tuesdays and Thursdays are the key days where we encourage on-site presence to engage in events and on-site activities. Responsibilities:

Work closely with GRAIL study team members to ensure that clinical and real-world data captured is complete, consistent, and accurate across all data sources.

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 EDC with external and real-world data sources (e.g., EHR, laboratory, registry, or other vendor-provided datasets).

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 across traditional clinical and real-world data sources.

Utilize programming skills to create listings and dashboards as required by study team members, including review and reconciliation of external or real-world datasets.

Lead data locking efforts, ensuring that study team members have executed according to the CDMP and that all contributing data sources are appropriately reviewed and documented.

Ensure that data integrity is maintained throughout the data lifecycle for sources including clinical data, external bio-specimen storage data, real-world data (RWD), 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 and/or review Data Transfer Plans (DTPs) with external data providers or collaborators, including vendors supplying real-world or observational data.

Assist the Director of Clinical Data Management and other GRAIL staff with developing and implementing data standards, controlled procedural documents, and software development efforts supporting both interventional and real-world data collection models.

Required Qualifications:

Bachelor's degree with 5+ years of industry experience in clinical data management within the pharmaceutical, biotechnology, diagnostics, or healthcare industry in an FDA-regulated environment, including experience supporting studies that incorporate real-world data (RWD) or real-world evidence (RWE) required.

Experience working on IDE trials and device registries within the medical device and/or pharmaceutical industry.

Prior experience leading mid to large scale clinical trials and ability to support multiple projects at a given time. 

Understanding of Real World Data (RWD) and Real World Evidence (RWE).

Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA).

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.

Familiarity with various data visualization, analytics, and reporting tools (e.g. tableau).

 Prior experience working on the sponsor side is required

Experience working on developing/reviewing standard operating procedures for clinical data management in collaboration with cross functional teams required.

Preferred Qualifications:

Advanced degree (with epidemiology, informatics) preferred.

Solid understanding of programming, analytics, or related disciplines is strongly desired.

Experience working with EDC systems, with some EDC build experience is preferred.

Experience programming in R, SAS, Python is preferred. 

Molecular diagnostics industry experience preferred.

Physical Demands and Work Environment:

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 hours, of your total work week be on-site.