Senior Biosample Clinical Research Project Manager

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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. **MEMBERS ONLY**SIGN UP NOW***. is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit ****rel=no-follow>****/>
As a Senior Bio-sample (Clinical Research) Project Manager, you will play a critical role in managing the testing of clinical trial samples within our laboratory. You will be strong in managing multiple trials simultaneously. You are a collaborative teammate 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:

• Work with CROs and Pharma partners for the execution of these clinical trials.
• Support the execution of clinical trials by leading operations related to molecular testing and provide guidance to the study team on appropriate course of actions throughout the clinical trial phase.
• Will serve as the primary POC for all internal and external teams on all Clinical Trial Laboratory Testing.
• 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, bio-sample management plans, vendor management plans, etc) in creative and effective ways that are scalable and reproducible
• Demonstrate solid 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 strong technical 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.
• 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 strong partnerships with internal and external cross-functional teams to promote an open, collaborative and productive environment.
• Complete day-to-day work and projects independently.
• Interact with external collaborators, develop workflows for samples transfers and disposition while finalizing documentation (i.e. MTAs, BMPs, etc) with little-to-no guidance
• Demonstrate strong external partnership management and acts as study representative on large-scale clinical studies involving multiple external collaborators. 

Your qualification and background will include:

• BA/BS with 5 years of experience, or Masters with 3 years of experience in Clinical Trial Management.
• Experience with Clinical Trial Laboratory testing highly desirable
• Ability to effectively manage multiple competing priorities and negotiate scope, requirements, and specifications across the organization
• 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

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 ****rel=no-follow>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.
,datePosted:2022-02-28T02:40:33 00:00,validThrough:2022-03-30T03:59:59 00:00,employmentType:FULL_TIME,hiringOrganization:{name:**MEMBERS ONLY**SIGN UP NOW***.,@id:400281,url:****Park, CA,address:{addressCountry:US,addressLocality:California,addressRegion:California,postalCode:94025,@type:PostalAddress},@type:place},industry:Clinical, Clinical Research, Regulatory,workHours:Full time,educationRequirements:Bachelors Degree,@type:JobPosting,@context:****

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