Senior Monitor

Salary: Full time starting salary is normally in the range £36,130 to £45,413 with potential progression once in post to £48,149

Contract Type: Fixed Term contract up to September 2028

Role Summary

The key responsibility of the Senior Monitor is to ensure appropriate on-site monitoring of the CRCTU trials portfolio (covering both adult and paediatric phase I-IV trials) is performed throughout the UK and other countries, thereby ensuring that a trial is run following the trial protocol and in accordance with current regulatory, ethical and quality standards. This will include overseeing the day-to-day management of a team of Monitors. The Senior Monitor is also actively involved in setting up and managing the monitoring of international trials to the appropriate quality standards.

Main Duties

• Manage CRCTU’s portfolio of trials with respect to on-site monitoring; maintain oversight of trials in development to allow for workload forecast, provide costings for on-site monitoring at the grant proposal stage and ensure Quality Management Plans (QMPs), covering the degree of on-site monitoring scheduled for a trial) are appropriately set up and are followed within the Quality Management Team throughout the duration of the trials.
• Contribute to the development of monitoring strategies and their implementation in the CRCTU. Collaborate on relevant projects with colleagues outside the CRCTU (e.g. within the University of Birmingham, CR UK or other UK Clinical Trials Units). Ensure that new skills, knowledge and best practice are disseminated appropriately internally and externally. This will involve presentations, working group membership and provision of training.
• Provide expert in-house up to date answers to day-to-day queries from CRCTU staff members regarding trial quality management, in-house and on-site monitoring and provide cover for the Quality Assurance Manager.
• Be able to use own initiative to solve trial quality management and staffing problems. In relation to monitoring the post holder would be expected to review procedures, taking action in amending any procedures that are no longer fit for purpose, recommending, developing and implementing new procedures, and training all staff in new procedures. To be responsible for future evaluations and validation processes.

Required Knowledge, Skills, Qualifications, Experience

Knowledge and Skills

• Proven knowledge of the international guidelines that govern clinical trials specifically with regard to monitoring. 
• Effective communication, negotiation, presentation, time management and interpersonal skills. 
• Ability to meet the travel needs of the post in the UK and further afield on occasion. Overnight stays between visits are required sporadically (2-3 times per year) and on occasion trips may include longer stays (up to 4 nights, Monday-Friday only).
• Ability to work on own initiative and problem solve. Capable of taking own decisions to organise the work of a professional team under management guidance.
• Demonstrate a critical and intelligent attention to detail and high standards of accuracy. 
• Proven ability to work to strict deadlines.

Informal enquiries to Charlotte Chapman, email: c.d.chapman@bham.ac.uk 

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