GRAIL
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured.
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Clinical Trial Manager/ Sr. Clinical Trial Manager at GRAIL (Remote)

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GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

The Clinical Trial Manager has overall responsibility to support Clinical Operations. This will include supporting overall day-to-day execution of a clinical trial, building strong internal and external relationships, managing clinical sites, and collaborating with cross functional teams. 
This position will require a candidate to have experience with working in a fast paced environment, ability to work in ambiguity, proactive in seeking and utilizing the resources available to effectively problem solve, ability to be flexible and creative yet ensuring the clinical trial is executed within compliance of regulations and of the highest quality, and to be able to identify areas of improvement to drive efficiency within Clinical Operations.

You will:

  • Manages all clinical operational aspects of a clinical trial from site selection, start-up, enrollment, maintenance, and close-out
  • Prepares and reviews study related plans and documents including protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans, and case report forms with minimal supervision
  • Participates in identifying, selecting, and monitoring the performance of clinical sitesEnsures proper site training and management, provides ongoing oversight of clinical site compliance with study plans, study protocol, SOPs, FDA regulations, ICH/GCP guidelines, and in accordance with all applicable regulations
  • Participates in EDC set-up by contributing to case report form design, user acceptance testing, completion guideline development and other related activities
  • Identifies any potential risks to the study timelines and/or conduct, proposes mitigations and implements mitigations with cross-functional team and manager support
  • Monitors clinical data entry progress and follows up on incomplete data entry and/or outstanding queries
  • Contributes to the development and management of site budgets and ensures invoice payment according to site payment terms
  • Works cross functionally with other departments such as Legal, Data Management, Biospecimen Management, and Finance on all aspects of the clinical trial
  • Provides oversight of regional monitors or contract research organizations (CRO)
  • Establishes and maintains strong relationships and communication with sites and site staff
  • Ensures Trial Master File (TMF) is current and maintained
  • Provides guidance and mentorship to CPAs (Clinical Project Assistants)

Your background should include:

  • 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 in sponsor organizations, 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 requirementsWorking 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 environmentStrong 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



GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

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What are GRAIL Perks + Benefits

GRAIL Benefits Overview

We’re committed to creating the best experience for everyone at GRAIL, ensuring that each member of our team has comprehensive benefits and resources to thrive at all stages of life, both at work and at home.

Culture
Friends outside of work
Eat lunch together
Intracompany committees
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Dedicated Diversity/Inclusion Staff
Unconscious bias training
Diversity manifesto
Mean gender pay gap below 10%
Diversity Employee Resource Groups
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Onsite Gym
Team workouts
Retirement & Stock Options Benefits
401(K)
Company Equity
Performance Bonus
Child Care & Parental Leave Benefits
Child Care Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Family Medical Leave
Company sponsored family events
Vacation & Time Off Benefits
Unlimited Vacation Policy
Paid Holidays
Paid Sick Days
Perks & Discounts
Casual Dress
Commuter Benefits
Free Daily Meals
Game Room
Happy Hours
Parking
Professional Development Benefits
Job Training & Conferences
Diversity Program
Cross functional training encouraged
Promote from within
Mentorship program
Online course subscriptions available

An Insider's view of GRAIL

How does your team reward individual success?

People grow their skills both by learning how to rapidly build scalable software systems, but also by partnering with scientists and other domain experts to better understand, model, and envision the systems we will need. We enable and empower our engineers to lead this process and grow with our systems as they make the future of GRAIL a reality.

Tristan Matthews

Senior Director, Software Engineering

What projects are you most excited about?

GRAIL has a unique opportunity to scale our operations to add value with our early detection test. Our automation team works on the full spectrum of projects from low-level instrument investigations to overall architectures of processing facilities. I'm excited by projects that push the boundaries of lab automation, and that's what GRAIL is doing.

David Jenions

Principal Automation Engineer

What does career growth look like on your team?

Our mission, to detect cancer early, is truly seeking a needle in many haystacks. Our lab has a very complex and sophisticated assay to execute. We leverage cross-training and mentorship programs where new teammates learn the ropes from senior staff. My team sets people up for success by turning tasks into learning opportunities.

Maryam Hosseini

Director, Laboratory Operations

How do your team's ideas influence the company's direction?

The biological problem we're trying to solve is a complex machine learning problem with human lives at stake. From a software engineering point of view, taking massive data, organizing it, building tools to mine it, and deliver results in a scalable, secure, and clinically compliant manner are areas of innovation. This, for me, is my dream job!

Satnam Alag

SVP, Software Engineering

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