Senior Clinical Data Analyst

Há 3 dias

Rondônia, Brasil beBeeData Tempo inteiro R$36.000 - R$84.000
Job Description

The Central Monitor is a vital role in the success of Phase I-IV clinical research and non-interventional studies. Their primary responsibility is to conduct centralized and prompt monitoring activities according to project plans, the protocol, ICH-GCP, and all applicable local and federal regulatory requirements.

Key Responsibilities:
  • Review and understand protocols, critical data processes, safety, and data integrity risks related to protocol execution.
  • Analyze site and study level data in applicable data analytics tools to identify risks and trends at the site and study level.
  • Assess factors affecting patient safety and clinical data integrity at an investigative site, such as protocol deviations and pharmacovigilance issues.
  • Synthesize data trends, issues, and action items for CRAs and other functional roles for follow-up.
  • Escalate serious issues to project teams and develop action plans with guidance.
Additional Responsibilities:
  • Contribute to the development of study-specific analytics strategy and work on advanced analytics.
  • Document observations during reviews and write queries, protocol deviations, and/or action items as needed for action by sites, CRAs, or other functional team members.
  • Perform prompt monitoring activities, remote data review at predefined time windows following data entry in the eCRF.
  • Prepare for and attend Investigator Meetings and/or Sponsor meetings.
Requirements:
  • Mastery of MS Office, with a focus on MS Excel, understanding of data analytics tools, and statistical analysis techniques, visualizations, and tools.
  • Ability to adapt quickly to changing priorities and achieve goals/targets with some oversight from the project team.

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