Senior Clinical Data Manager # 4426 jobs in United States
cer-icon
Apply on Employer Site
company-logo

GRAIL · 7 hours ago

Senior Clinical Data Manager # 4426

GRAIL is a healthcare company focused on pioneering technologies for early cancer detection. The Senior Clinical Data Manager will lead data management activities for diagnostic product development studies, ensuring data integrity and collaborating with various teams to support GRAIL's clinical development pipeline.

BiotechnologyHealth CareHealth DiagnosticsMedicalMedical Device
check
H1B Sponsor Likelynote

Responsibilities

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

Qualification

Clinical Data ManagementEDC SystemsProgramming in RProgramming in SASRegulatory KnowledgeInterpersonal CommunicationOrganizational Skills

Required

Requires 5+ years of industry experience required 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

Preferred

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

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 is a healthcare company that develops pan-cancer screening tests designed to detect cancers at an early stage.

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 Company
Total Funding
$2.44B
Key Investors
ARCH Venture PartnersIllumina
2025-10-20Post Ipo Equity· $325M
2025-10-16Post Ipo Equity· $110M
2024-06-13IPO

Leadership Team

leader-logo
Satnam Alag
Senior Vice President Software Engineering and Chief Security Officer
linkedin
leader-logo
Joshua J. Ofman
President
linkedin
Company data provided by crunchbase