Manager, Clinical Data Manager

  • Competitive
  • Redwood City, United States
  • Permanent
SUMMARY :We have partnered with a  clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases.
This Clinical Data Manager reports to the head of Biostatistics, and plays a key role in the development of data management strategies including outsourcing and oversight strategies, standards, and processes. 

  • Responsible for all clinical data management owned deliverables and ensure that all data management related milestones are met.
  • Operational responsibility from reviewing protocols to identify data management requirements.
  • Oversee data management vendor activities including consistency, quality and timeliness of all data management deliverables in compliance with ICH/GCP guidelines, Regulatory Authorities' regulations/guidelines, and applicable SOPs.
  • Author or oversee the development of all Clinical Data Management (DM) 
  • Engage in data reviews and data cleaning activities with the study team to ensure data quality.
  •  Oversee data vendor through review, cleaning, auditing, validation procedures and ensure data handling compliance with regulatory requirements.
  • Lead and participate in cross functional data review and report on performance and quality; review clinical data within studies and across for trend analysis. 
  •  Create and maintain trackers, dashboards, metrics to monitor DM activities.
  •  Develop processes, guidelines, data standards, and SOPs related to Data Management.
  • Perform responsibilities in compliance with SOPs, ICH/GCP guidelines in accordance with regulatory, legal and ethical standards.

  •  Bachelor's degree or higher with relevant experience of at least 5 years working in data management and at least 3 years as a clinical data manager at a study/project level.
  • Detail oriented with knowledge of clinical operations and clinical data flow. 
  • Familiarity with Base SAS preferred.
  • Excellent communication and interpersonal skills.
  •  Strong collaborative skills and ability to work with a cross-functional team.
Salary Range: $140,000 – 160,000
Leila Johnston Division Manager

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