Senior Clinical Data Manager | GenomeWeb

Senior Clinical Data Manager

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

 The Senior Clinical Data Manager will implement the rigorous and scalable systems required to robustly manage GRAIL’s clinical data from GRAIL’s program of clinical studies. 

  • Work closely with GRAIL Clinical Operations, Medical Directors, and collaborators on clinical studies from startup to database lock to produce high-quality study data.
  • Hold accountability for clinical database integrity and accuracy on individual studies.
  • Review protocols and provide input relevant to data management issues.
  • Manage data management study activities with vendors including DB build, UAT, maintenance, and lock.
  • Be responsible for study-specific data management documentation (e.g. DM Plan, database creation/validation, and query generation/resolution).
  • Assist the Lead of Data Management with developing and implementing data management standards, processes, policies and associated documents
Requirements

PREFERRED BACKGROUND

  • 8+ years of clinical data management experience, including database setup, data cleaning, validation and consistency checks, initiation and closure of trial databases, CRF design, and query resolution.
  • 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.
  • 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 high­intensity sequencing analysis of circulating cell­free 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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