Centralized Monitoring Lead

hace 1 semana


Xico, México Novasyte A tiempo completo

Job Overview

As a Centralized Monitoring Lead at Novasyte, you will play a pivotal role in ensuring the execution of assigned clinical studies from initiation to closeout. Your primary focus will be on managing project deliverables in accordance with standard operating procedures (SOPs), policies, and practices. You will provide critical support and assistance across multiple projects, sites, and teams, reviewing structured clinical data output with access to medical charts.

Main Responsibilities:

  • Develop and implement study management plans and/or risk-based monitoring specific tools and templates to evaluate the quality and integrity of the study.
  • Support project management teams in developing monitoring strategies, including monitoring triggers/thresholds.
  • Manage operational insights of assigned projects and complete study/site metrics trending, analyzing clinical aspects of the trial, sharing trends, and agreeing on action plans.
  • Review, triage, and act upon clinical study alerts, monitor clinical operation plan (COP) compliance, and ensure overall completeness and accuracy of patient information.
  • Perform Subject Level Data Review independently or as part of a dual role, if required, for assigned sites.
  • Conduct remote monitoring visits for assigned sites as needed.

Key Performance Indicators:

  • Trend analysis of clinical aspects of the trial.
  • Site-level KRIs and historic site performance review according to Central Monitoring Plan.
  • Early identification of site-level risk/issue(s).
  • Timely corrective actions (e.g., Site Telephone Contact or Triggered Onsite Monitoring Visit).
  • Effectiveness of recommended actions.

Required Skills and Qualifications:

  • Strong understanding of SOPs, policies, and practices in clinical research.
  • Excellent analytical and problem-solving skills.
  • Ability to work independently and collaboratively as part of a team.
  • Effective communication and interpersonal skills.
  • Proficiency in using clinical data management systems and software.

Benefits:

  • Competitive salary: $80,000 - $110,000 per year.
  • Ongoing professional development and training opportunities.
  • A dynamic and supportive work environment.
  • A comprehensive benefits package, including health insurance, retirement planning, and paid time off.

Location: This role is based in the United States, with opportunities for remote work. The ideal candidate will have a strong background in clinical research and a passion for delivering high-quality results.



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