Quality Assurance Manager

THE INSTITUTE OF CANCER RESEARCH; Greater London; On-site; GBP 50,000 - 62,000; Part time

Job summary

A leading cancer research institute is seeking a Quality Assurance Manager to oversee quality assurance systems for clinical trials. The role involves conducting audits, providing QA leadership, and ensuring compliance with regulations. The successful candidate will have expertise in quality systems and excellent communication skills.

Qualifications

• Expert knowledge of quality systems in clinical research.
• Proven track record in audits and developing SOPs.

Responsibilities

• Design and implement quality assurance systems for clinical trials.
• Conduct audits of clinical trial documentation and procedures.

Skills

Quality Assurance

Communication

Organizational Skills

Job description

£50,825 - £61,525 full time equivalent (salary will be pro rata to 21 hours)

Salary: Commencement on the salary range is subject tocomparableskills and experience.

Duration ofContract: Fixed Term for 2 years

Hours per week : Part time, working 21 hours a week (0.6 FTE). Hours/ days of work to be by mutual agreement.

Location: This is an office based role. Requests for hybrid working (splitting time between our Sutton site and home) may be considered following successful completion of the probation period/key training and if the role allows. Flexible working options may be considered.

We would like to appoint a Quality Assurance Manager to be responsible for the design, implementation, maintenance and ongoing improvement of the quality assurance systems of ICR Clinical Trials. The post holder will report to the ICR-CTSU Assistant Operations Director and will provide QA leadership to the joint ICR-CTSU/DDU IIT Quality Assurance Review Team (a multidisciplinary team of trial managers, statisticians, data managers, IT specialists and research administrators with responsibility for on-going review of the quality management system).

The post holder will plan, coordinate and conduct audits of clinical trial documentation and procedures and be responsible for ensuring procedures are fit for purpose and commensurate with level of risk. The post holder will provide quality assurance advice and support to colleagues within ICR-CTSU and DDU IIT and represent ICR-CTSU at relevant meetings within the wider ICR and Royal Marsden (RM) institutions and nationally, as required.

ICR-CTSU is in the process of implementing cloud-based e-trial solutions, including eTMF, to support their trials portfolios. The post-holder will have a key role in ensuring quality processes for implementation and on-going use.

Key Requirements

The successful candidate will have expert knowledge of quality systems in clinical research and a proven track record in the design, conduct and reporting of audits and the development and management of an annual audit program. Experience of developing Standard Operating Procedures and management of a Quality Management System is also essential. Candidates will have working knowledge of the Medicines for Human Use (Clinical Trials Regulations) 2004, Data Protection Act (1998), GCP and Research Governance. Experience and working knowledge of pharmacovigilance reporting is preferable. Candidates must demonstrate effective verbal and written communication and have excellent organisational skills.

Department/Directorate Information

The ICR's Clinical Trials and Statistics Unit ( ICR-CTSU ) is seeking a Quality Assurance Manager to join their team at ICR’s Sutton site in Surrey. ICR-CTSU runs a diverse portfolio of national and international phase III multicentre randomised controlled trials, and phase II trials of targeted treatments with a focus on breast, urological and head and neck cancer treatments. The post-holder will also work with the ICR’s Drug Development Unit (DDU ) to align Quality Assurance activities across ICR sponsored clinical trials. The DDU specialises in first-in-human trialsand provides a pathway from pre clinical drug discovery through to proof of principle phase I trials and tumour specific evaluation of novel agents .

We encourage all applicants to access the job pack attached for more detailed information regarding this role.

About The Institute of Cancer Research

Why work for us?

As a member of staff, you'll have exclusive access to a range of staff benefits .

The ICR is committed to supporting overseas applicants applying for roles, please click here to find out further information.

The Institute of Cancer Research, London, is one of the world's most influential cancer research institutes, with an outstanding record of achievement dating back more than 100 years. Further information about working at the ICR can be found here .

At the Institute of Cancer Research, we champion diversity as we believe it fuels innovation and drives impactful research. We welcome applicants from all walks of life, valuing diverse perspectives that enrich our work.

Don't let a checklist of qualifications hold you back – if you're passionate about the role, we want to hear from you. Your unique experiences and backgrounds contribute to the richness of our team. We are committed to being an equal opportunity for all, regardless of ethnicity, gender, age, sexual orientation, disability, or any other dimension of diversity. Join us in creating an inclusive environment where everyone's voice is heard and valued.

£50,825 - £61,525 full time equivalent (salary will be pro rata to 21 hours)