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Central Monitor

Location
Nottingham, Nottinghamshire
Job Type
Permanent
Posted
30 Aug 2022
Who we are

We re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of almost 2,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

What a Central Monitor does at Worldwide

A Central Monitor will conduct central monitoring activities for assigned clinical trials in accordance with ICH GCP E6 requirements.

What you will do

Understands the assigned protocol and ensures central monitoring activities are planned and executed in alignment with it and in adherence to ICH-GCP, SOPs, corporate standards and regulatory requirements.
Perform central monitoring activities including review of system outputs, identification of outliers, trends or signals and propose actions for assessment by study team. Follow-up with study teams as appropriate for action or issue resolution.
Understands the study budget for their assigned tasks.
Can provide subject matter expertise for the delivery of the centralized monitoring strategy required for the trial.
As required, develops and delivers training to the study team regarding the centralized monitoring strategy.
Ensures the documentation of the centralized monitoring strategy in the appropriate functional plan and/or development of the central monitoring plan.
Depending on experience, may contribute, along with other functional representatives, to the identification of critical data and processes and the development of the Risk Planning Tool.
Depending on experience, may contribute to the cross-functional review of risks throughout the trial.
Ensures Inspection Readiness for centralized monitoring scope.
Conducts and documents study/site level review of Key Risk Indications/Key Performance Indicators and where required, statistical monitoring and tracking of study Quality Tolerance Limits
To participate as required in sponsor meetings and audits or other third-party meetings.

What you will bring to the role

Excellent communication, presentation, and interpersonal skills.
Excellent planning and organizational skills with effective time management
Excellent interpersonal skills
Knowledge of clinical project financial principles
Ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identify and mitigate potential threats to the successful conduct of a clinical research project.
Critical thinking and analytical skills to understand/ analyze complex data and provide insight into risk reports, trends and outliers in data
Computer literate and numerate with a willingness to adapt to various computer systems.

Your experience

BSc/RN or equivalent combination of knowledge, skills and experience
Prior experience of Central Monitoring and associated ICH/Regulatory guidance required
Demonstrates critical thinking skills to determine the cause and appropriate solution in the identification of issues.
Demonstrated capability of working in global environment

Why Worldwide

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient s life depends on it - because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

Interested in hearing more about Worldwide or our roles? Check out our careers page at !

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Details

  • Job Reference: 698045419-2
  • Date Posted: 30 August 2022
  • Recruiter: Worldwide Clinical Trials
  • Location: Nottingham, Nottinghamshire
  • Salary: On Application
  • Sector: Science & Technology
  • Job Type: Permanent
  • Start Date: Sat, 27 Aug 2022 19:00:00 EST