GRAIL · 8 hours ago
Senior Clinical Data Manager (RWE/RWD) # 4426
Menlo Park, CA
Full-time
Hybrid
Mid, Senior Level
$109K/yr - $144K/yr
5+ years expGRAIL is a healthcare company pioneering new technologies to advance early cancer detection. The Senior Clinical Data Manager will lead data management activities for diagnostic product development studies, ensuring data integrity and supporting clinical development pipelines.
BiotechnologyMedical DeviceHealthcareHealth CareHealth DiagnosticsMedical
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
Qualification
Required
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
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
Benefits
Flexible time-off or vacation
A 401(k) retirement plan with employer match
Medical, dental, and vision coverage
Carefully selected mindfulness programs
Company
GRAIL
Grail is a healthcare company that develops pan-cancer screening tests designed to detect cancers at an early stage.
1001-5000 employees
H1B Sponsorship
GRAIL has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (21)
2024 (26)
2023 (23)
2022 (46)
2021 (25)
2020 (9)
Funding
Current Stage
Public CompanyTotal Funding
$2.44BKey Investors
Samsung C&T Corporation,Samsung Electronics6 Dimensions Capital,Ally Bridge Group,Hillhouse Investment,Huangpu River CapitalARCH Venture Partners
2025-10-20Post Ipo Equity· $325M
2025-10-16Post Ipo Equity· $110M
2024-06-13IPO
Leadership Team
Satnam Alag
Senior Vice President Software Engineering and Chief Security Officer
Joshua J. Ofman
President
Recent News
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2026-02-09
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