Clinical Data Management Lead | GenomeWeb

Clinical Data Management Lead

Organization
GRAIL, Inc.
Job Location
Redwood City, CA
Job Description

 The Lead, Clinical Data Management will define and implement the rigorous and scalable systems and processes required to robustly manage clinical data from GRAIL’s program of clinical studies. 

  • Building and managing the Clinical Data Management function and serving as a working data manager.
  • Works closely with GRAIL Clinical Operations, Medical Directors, and collaborators on clinical studies from start-­up to database lock to produce high­-quality study data.
  • Developing and implementing data management standards, processes, policies, SOPs and associated documents, ensuring rigor and scalability
  • Accountable for database integrity and accuracy across all clinical programs
  • Serve as an integral member of clinical study teams
  • Manage, mentor, and guide the professional development of team members.
  • Staying abreast of industry developments in the Clinical Data Management field and apply to appropriate systems or processes
Requirements

PREFERRED BACKGROUND

  • 10+ years of clinical data management experience, including EDC selection and set-­up, database set-­up, data cleaning, validation and consistency checks, initiation and closure of trial databases, CRF design, and query resolution, with >5 years management experience
  • Proficiency in the use of clinical data management systems, including EDC systems and online enrollment
  • Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA
  • Strong written and oral communication skills.
  • Strong team player with demonstrated track record of success in cross­-functional team environment and management roles.
  • Molecular diagnostics industry experience.
  • Experience programming in SAS. 
About Our Organization

GRAIL, Inc. is developing paradigm-changing clinical assays for early cancer detection, based on unique biological insights from high-­intensity sequencing analysis of circulating cell-­free nucleic acids. We are seeking passionate and talented individuals to join us in realizing our mission, which has the potential to dramatically reduce the global burden of cancer.

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