Senior Clinical Trial Manager # 4398 at GRAIL

Menlo Park, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical TechnologyIndustries

Requirements

Experience in clinical trial management, preferably in a fast-paced environment
Ability to work in ambiguity and proactively seek resources to solve problems
Proactive in seeking and utilizing resources to effectively solve problems
Ability to be flexible and creative in problem-solving
Ensuring clinical trials are executed within compliance of regulations and of the highest quality
Ability to identify areas of improvement to drive efficiency within Clinical Operations
Strong leadership and management skills, with experience guiding study leads and teams
Excellent communication and interpersonal skills, with ability to partner with cross-functional teams
Experience with site management, performance oversight, and compliance with study protocols and regulatory requirements
Strong analytical and problem-solving skills, with ability to develop study-related plans and documents
Experience with EDC setup, case report form design, and data quality
Ability to manage clinical data entry progress and contribute to the development of site budgets
Experience with invoice payments and financial management
Ability to identify and mitigate risks to ensure successful execution of clinical trials
Strong understanding of regulatory requirements, including GCP/ICH

Responsibilities

Serve as Clinical Operations Study Lead for assigned studies
Provide strategic and operational leadership to ensure successful planning, execution, and delivery of clinical studies
Support and guide Clinical Trial Managers and Clinical Project Assistants
Act as the primary point of contact for internal cross-functional teams
Lead site management and performance oversight, including site relationships and compliance with study protocols and regulatory requirements
Develop study-related plans and documents, including informed consent forms
Collaborate on site identification and selection
Participate in EDC setup and contribute to case report form design
Oversee clinical data entry progress and resolve incomplete data and outstanding queries
Contribute to the development and management of site budgets and ensure timely and accurate invoice payments
Partner with cross-functional stakeholders to define study strategy and proactively identify and mitigate risks
Provide oversight of regional study monitors and/or contract research organizations (CRO)
Facilitate external communication with site staff and pharmaceutical partners
Ensure electronic Trial Master File (eTMF) is current and maintained
Collaborate with other departments to identify areas of improvement and drive efficiency within Clinical Operations

Skills

Key technologies and capabilities for this role

Clinical Trial ManagementClinical OperationsStudy ExecutionRegulatory ComplianceProblem-SolvingStakeholder ManagementCross-functional Collaboration

Questions & Answers

Common questions about this position

What is the employment type for this Senior Clinical Trial Manager position?

This is a full-time position.

Is this role remote or does it require working from specific locations?

This information is not specified in the job description.

What key skills and qualities are needed for the Senior Clinical Trial Manager role?

The role requires experience working in a fast-paced environment, ability to work in ambiguity, proactive problem-solving, flexibility, creativity, and ensuring compliance with regulations while driving efficiency.

What is the company culture like at GRAIL?

GRAIL has built a multi-disciplinary organization of scientists, engineers, and physicians, working in a fast-paced environment to pioneer technologies for early cancer detection, emphasizing operational excellence, cross-functional collaboration, and compliance.

What makes a strong candidate for this Senior Clinical Trial Manager position?

Strong candidates have experience leading clinical operations in fast-paced settings, managing sites and cross-functional teams, ensuring regulatory compliance, and driving study execution from start-up to close-out with proactive problem-solving.

GRAIL

Develops blood tests for early cancer detection

About GRAIL

GRAIL focuses on improving cancer detection through advanced blood tests that identify cancer at its earliest stages, enhancing treatment success rates. The company utilizes high-intensity sequencing to analyze tumor genome data, employing algorithms and deep learning to extract actionable information for early cancer detection. GRAIL differentiates itself from competitors by its commitment to large-scale clinical studies that validate the effectiveness of its tests. The primary goal is to reduce global cancer mortality by enabling early diagnosis, making the disease more treatable.

Menlo Park, CaliforniaHeadquarters

2016Year Founded

$1,765.5MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.

Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.

Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.

Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.

Risks

Potential overdiagnosis could impact the perceived value of GRAIL's tests.

Significant net losses may affect investor confidence and long-term sustainability.

High test costs may limit accessibility in markets with less healthcare funding.

Differentiation

GRAIL uses high-intensity sequencing for early cancer detection via blood tests.

The Galleri test screens for over 50 cancers with a single blood draw.

GRAIL's tests are supported by large-scale clinical studies ensuring reliability.

Upsides

Collaborations with platforms like Function Health expand Galleri test accessibility.

Revenue from Galleri grew 52% year-over-year, indicating strong market demand.

GRAIL's technology aligns with trends in personalized and preventative medicine.

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