Senior Biosample Operations Project Manager

Employer
GRAIL, Inc.
Location
Menlo Park, CA, United States
Posted
Jul 17, 2021
Ref
1185673452
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.

As a Senior Biosample Operations Project Manager, you will play a meaningful role in ensuring that our bio-specimens are of the highest quality and are utilized with corporate integrity and rigor. You are a collaborative team player and demonstrate a strong track record of success in a cross-functional team environment guiding development of complex workflows and processes to meet business goals.

You will:

• Use professional and industry concepts in accordance with company objectives to contribute to the development of processes to solve complex problems (e.g. develop sample workflows, reconciliation plans, biosample management plans, vendor management plans, etc) in creative and effective ways that are scalable and reproducible
• Demonstrate proven understanding of clinical principles, applicable laws, regulations and guidelines that promote the highest level bio-specimen and data quality and support adherence to ethical and legal requirements, including but not limited to ICH, GCP and GLP
• Demonstrate proficiency of project management principles and concepts including identification and management of product scope, defining and tracing requirements, creating project plans and managing timelines with various dependencies.
• Support the execution of clinical trials by leading operations related to sample management and can guide the study team on appropriate courses of action as it relates to specimen handling and collections.
• Work on problems of diverse scope (i.e. sample reconciliation) where analysis of situations or data requires evaluation of identifiable factors
• Exercises independent decision making that impact study operations and overall study conduct.
• Maintain positive relationships with internal and external cross-functional teams to promote an open, collaborative and productive environment.
• Complete day-to-day work and projects with little-to-no mentorship from team leads and managers
• Interact with external collaborators, develop workflows for samples transfers and disposition while finalizing documentation (i.e. MTAs, BMPs, etc) with little-to-no mentorship
• Demonstrate strong external partnership management and acts as study representative on large-scale clinical studies involving multiple external collaborators.

Your background will include:

• BA/BS with 5 years of experience, or Masters with 3 years of experience
• Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.
• Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA, GDPR, MHRA
• Ability to work as part of a team within a highly collaborative environment.
• Ability to communicate effectively in verbal, writing, and presentations and meet deadlines

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

GRAIL, Inc. and its affiliates and subsidiaries ("GRAIL") does not accept any liability for fees for resumes from recruiters or employment agencies ("Agency"), without a binding, written recruitment agreement between GRAIL and Agency describing the services and specific job openings ("Agreement"). GRAIL may consider any candidate for whom an Agency has submitted an unsolicited resume and explicitly reserves the right to hire those candidate(s) without any financial obligation to the Agency, unless an Agreement is in place. Any email or verbal contacts with any person within GRAIL is inadequate to create a binding agreement. Agencies without an Agreement are requested not to contact any hiring managers of GRAIL with recruiting inquiries or resumes. Agencies interested in partnering with GRAIL may contact GRAIL's HR Department through our Customer Service team .