Senior Clinical Trial Manager # 4398 jobs in United States
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GRAIL · 2 days ago

Senior Clinical Trial Manager # 4398

GRAIL is a healthcare company pioneering new technologies to advance early cancer detection. The Sr. Clinical Trial Manager serves as a clinical operations leader, responsible for guiding the execution of clinical trials and ensuring operational excellence and timely delivery of study milestones.

BiotechnologyHealth CareHealth DiagnosticsMedicalMedical Device
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H1B Sponsor Likelynote

Responsibilities

Serves as the Clinical Operations Study Lead for assigned studies, providing strategic and operational leadership to ensure successful planning, execution, and delivery of clinical studies
Supports and guides Clinical Trial Managers and Clinical Project Assistants ensuring alignment of study activities, promoting best practices, and driving a unified approach to achieve study objectives
Acts as the primary point of contact for internal cross functional teams
Leads site management and performance oversight, including ensuring proper training, fostering strong site relationships, and monitoring compliance with study protocols, plans, SOPs, GCP/ICH, and all applicable regulatory requirements
Manages all clinical operational aspects of a clinical trial from site selection, start-up, enrollment, maintenance, and close-out
Develops study related plans and documents, including informed consent forms, ensuring alignment with study objectives, regulatory requirements, and overall study strategy
Collaborates on site identification and selection
Participates in EDC set-up by contributing to case report form design, user acceptance testing, development of completion guidelines, and other related activities, supporting study requirements and data quality
Oversees clinical data entry progress ensuring timely resolution of incomplete data and outstanding queries
Contributes to the development and management of site budgets and ensures timely and accurate invoice payments in accordance with site payment terms
Partners with cross functional stakeholders such as Clinical Data Management, Biospecimen Management, Finance, Clinical Compliance, Clinical Science, and Lab Operations to define study strategy, align operational plans, and proactively identify and mitigate risks to ensure successful execution
Provides oversight of regional study monitors and/or contract research organizations (CRO) to ensure quality, compliance, and timely study execution while proactively addressing risk and performance issues
Facilitate external communication with site staff and pharmaceutical partners (as applicable)
Ensures electronic Trial Master File (eTMF) is current and maintained
These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion

Qualification

Clinical trial managementGCP knowledgeICH guidelinesElectronic data captureVitro diagnosticsMicrosoft OfficeGoogle suiteInterpersonal communicationOrganizational skills

Required

Bachelor's degree or equivalent in the life sciences or related field required
Additional coursework in clinical trial planning and execution is strongly desired
Ideal candidate will have at least 5 years of relevant experience in managing clinical trials, with at least 2 years experience in a Clinical Operations study lead role, at a sponsor company (pharma, biotech, or medical device) with a strong track record of successful trial initiation and execution
Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable
Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements
Working experience with an electronic data capture system, CTMS system, and eTMF system
Strong interpersonal communication (written and verbal), organizational and prioritization skills
Able to work effectively under a fast-paced and changing environment
Strong work ethic and demonstrated ability to deliver assignments on time
Proficient with office automation tools, such as Microsoft Office and the Google suite of apps

Benefits

Flexible time-off
A 401(k) with a company % match
Medical, dental, and vision insurance plans
Carefully selected mindfulness offerings

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

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