Regulatory and Governance Affairs Manager

University of Leeds

Leeds, United Kingdom

ID: 7100202 (Ref.No. MHCTR1234)
Posted: May 17, 2022

Job Description

We are looking for a Regulatory and Governance Affairs Manager to lead the Quality Assurance department of a large nationally-leading clinical trials unit.

As Regulatory and Governance Affairs Manager you will lead and manage the LICTR quality control and assurance function ensure compliance of clinical trials activity across the three LICTR Divisions (Cancer, Complex Interventions, Surgical Interventions, Diagnostics and Devices) with all relevant regulations, legislation and good practice in relation to the conduct of clinical trials. You will be responsible for the Quality Assurance team of staff in managing the LICTR quality management systems, quality assurance and on-site monitoring functions. You will manage the Quality Assurance Department with a high degree of autonomy but will be expected to regularly report on LICTR compliance with all regulations relevant to clinical trials and any critical issues to the Operations Director and Division Directors.  

You will have substantial experience of the management, monitoring or audit of phase I/II/III clinical trials to current UK regulatory standards and an up-to-date knowledge of regulatory frameworks, clinical trials legislation and information governance. As you will work closely with multiple stakeholders you will need excellent communication and interpersonal skills, along with the ability to lead a team and meet project deadlines. 


To explore the post further or for any queries you may have, please contact: 

Anna Hockaday, Operations Director 

Email: [email protected], or

Vicky Napp, Operations Director 

Email: [email protected]


The University of Leeds is committed to providing equal opportunities for all and offers a range of family friendly policies. The School of Medicine holds a Gold Athena Swan award.  We are committed to being an inclusive Medical School that values all staff, and we are happy to consider job share applications and requests for flexible working arrangements from our employees. 

 

As an international research-intensive university, we welcome students and staff from all walks of life and from across the world. We foster an inclusive environment where all can flourish and prosper, and we are proud of our strong commitment to student education. Within the Faculty/School of Medicine we are dedicated to diversifying our community and we welcome the unique contributions that individuals can bring, and particularly encourage applications from, but not limited to Black, Asian, people who belong to a minority ethnic community, people who identify as LGBT+; and people with disabilities. Candidates will always be selected based on merit and ability.  

Location:  Leeds - Main Campus
Faculty/Service:  Faculty of Medicine & Health
School/Institute:  Leeds Institute of Clinical Trials Research (LICTR)
Category:  Professional & Managerial
Grade:  Grade 8
Salary:  £42,149 to £50,296 p.a.
Working Time:  full time or part time hours to be discussed
Post Type:  Full Time/Part Time
Contract Type:  Fixed Term (Available for 36 months due to external grant income)
Release Date:  Monday 16 May 2022
Closing Date:  Monday 13 June 2022
Reference:  MHCTR1234


The University community is made up of a wide range of people with diverse backgrounds and circumstances, which we value and regard as a great asset. As part of our continued commitment to equality and inclusion, we strive to create an environment where everyone can reach their full potential and have a real opportunity to participate in and contribute to our activities.