Trial Management Team Leader

Job Purpose

The role of the post is to lead a team of trial management staff responsible for administration of a portfolio of clinical trial research projects. The Team Leader will assist the Trials Unit Directors in developing and maintaining the trials portfolio, promoting the trial activities locally as well as at an (inter)national level. They will oversee the administration of their clinical trials portfolio from concept to completion, taking an active role in providing specialist trial management advice, contributing to the design and costing of new trial proposals, preparing grant applications, coordinating trials (when necessary) and contributing to the presentation and publication of results. They will be responsible for ensuring that the team’s portfolio of trials is conducted according to applicable regulations and quality standards. They will be responsible for all aspects of staff management and will plan and monitor team finance and staff resource. They will contribute to the operation of the CRCTU by representing the team on the Operational Management Committee and take an active role in developing the CRCTU’s quality management system.

Person Specification

• Higher degree) in a relevant biomedical or associated subject with strong experience of working in academic clinical trial management undertaking sponsor related duties, including experience of managing Investigational Medicinal Product clinical trials, experience in devices and diagnostics trials
• An in-depth understanding of clinical trial research, the regulations and guidance governing clinical trials in the UK and trial management methodology.
• Proven ability to coordinate academic clinical trials, preferably covering all steps from design to publication. Experience of writing trial documentation (e.g. protocols and Case Report Forms) and reports, and data management essential. Experience of writing grants and contributing to trial design desired. Ability to define policy and procedure.
• Proven administrative and project management skills.
• Proven ability to supervise, mentor, train and manage staff; including recruitment and appraisals.
• Office management skills that include excellent word-processing, utilization and querying of clinical trial databases, and budget control.
• Able to work on own initiative and problem solve while constantly prioritising work of self and others. Proven ability to multitask.
• Excellent communication, negotiation, presentation and inter-personal skills.
• Must demonstrate a critical and intelligent attention to detail and high standards of accuracy.
• Ability to meet the travel needs of the post nationally and internationally on occasion.