Premier Research is looking for a Central Monitor II to join our Global Clinical Strategy and Delivery team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
* We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
* Your ideas influence the way we work, and your voice matters here.
* As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
What You'll Be Doing
* Conducting ongoing reviews of clinical trial data using various technologies, analytic and visualization tools to monitor the quality of data, patient safety and relevant risks as per the Risk Assessment for the study.
* Monitoring site and / or study performance, data trending related to quality and site performance and escalation to the appropriate functional team lead.
* Communicating Data Analytics Insights of potential risks or identified issues that could pose a risk to subject safety and data integrity.
* Develops Risk Analytics Monitoring Plan for assigned projects.
* Presents central monitoring findings to the internal team and sponsor teams on a predetermined frequency.
What We Are Looking For
* Bachelors (or equivalent) in the biological sciences, computer sciences, mathematics, or data sciences and / or related disciplines in the health care domain
* For a Central Monitor level I - will require 1-2 years' experience in Clinical Data Science or Clinical Research experience (Site Operations, Monitoring on-site / remote).
* For a Central Monitor level II - will require 2-5 years' experience in Clinical Data Science or Clinical Research experience (Site Operations, Monitoring on-site / remote).
* Global study experience preferred.
* Knowledge and implementation of ICH GCP E6 R2 & R3 guidelines.
* Experience of supporting risk-based monitoring.
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