Clinical Records Associate Manager

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 Records Associate Manager is responsible for working with study teams managing the Trial Master File (TMF) across all GRAIL studies. The Clinical Records Associate Manager acts as a liaison between Clinical Operations/Functional Area teams and Clinical Systems and Records Management, in the area of Records Management. This individual ensures all documents within GRAILs eTMF are complete, and in keeping with GRAILs standards for how processed records are to be kept in order to be inspection ready in accordance with ICH GCP and BIMO standards. This role will work closely with study teams and other members outside of Clinical Systems and Records Management. 
Your tasks and responsibilities will include:

• Represent Clinical System and Records Management at Clinical study team meetings
• Maintain monthly metrics of document flow
• Process documents as necessary
• Identify gaps in study documents
• Work with Clinical Compliance on inspection readiness activities
• Create/Maintain study expected document list within eTMF
• Manage dashboards in Veeva that house metrics
• Participate in Veeva upgrade and validation activities
• Collaborate with Functional Area groups about GDP
• Raise any issues with AD of Clinical Systems and Records Management
• Other related duties as assigned

Your background and qualifications will include:

• Minimum experience 6-8 years
• Strong knowledge of Veeva Vault eTMF
• Proficiency with creating and providing metrics
• Strong attention to detail
• Ability to identify issues and report to proper team member(s)
• Knowledge of ICH GCP (Part 11) knowledge of DIA Reference Model
• Knowledge of ALCOA+
• Some knowledge of preparing for FDA Inspection
• Comfortable working cross functionally
• Comfortable presenting in meetings when necessary
• Self-starter
• Excellent communication skills 

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.