Regulatory and Governance Affairs Manager

We are looking for a Regulatory and Governance Affairs Officer to play a key short-term role in the Quality Assurance department of a large nationally leading clinical trials unit.

Do you have excellent knowledge of UK regulatory and governance requirements relating to clinical trials research?

Do you have experience of audit and quality management in clinical trials? 

Do you want to be part of a leading team that has a national and international reputation for excellence in conducting complex, multi-centre clinical trials?

The Leeds Institute of Clinical Trials Research is an international leader in the field of clinical trials. The Unit is one of the largest in the UK and conducts national and international randomised and early phase clinical trials in a variety of clinical fields. Our main aim is to support the challenge of changing clinical practice for the better and our past results and current work have already helped to do this. Our results inform the academic development of this specialised field of clinical research on a national and international level. Particularly, we specialise in complex phase III trials, efficient phase I/II trials, biomarker driven designs, seamless phase II/III designs, adaptive designs and the development and evaluation of complex interventions.

You will lead and manage the CTRU quality control and assurance function within the CTRU to ensure compliance of clinical trials activity across the three CTRU Divisions 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 CTRU 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 CTRU 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 and clinical trials legislation. 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.

What we offer in return 

26 days holiday plus approx.16 Bank Holidays/days that the University is closed by custom (including Christmas) – That’s 42 days a year! 

Generous pension scheme options plus life assurance 

Health and Wellbeing: Discounted staff membership options at The Edge, our state-of-the-art Campus gym, with a pool, sauna, climbing wall, cycle circuit, and sports halls. 

Personal Development:

-Access to courses run by our Organisational Development & Professional Learning team. 

-All FMH staff are entitled to ten days staff development per year (pro rata). Please speak to your Line Manager about how you can utilise these.

Access to on-site childcare, shopping discounts and travel schemes are also available. 

Please note that this post may be suitable for sponsorship under the Skilled Worker visa route but first-time applicants might need to qualify for salary concessions. For more information please visit: www.gov.uk/skilled-worker-visa.

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

Geraldine Murden, Deputy Director (Operations)

Email: G.A.Murden@leeds.ac.uk

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