King's College London

KCTU Quality Assurance Manager

Source: Talent GB

Building and Campus: Denmark Hill Campus

Contact:

Job description

The post holder will work within the King’s UKCRC fully registered Clinical Trials Unit (KCTU), supported by the operational director, core team and heads of affiliated groups including, statistics, pharmacists, health economics etc.

The purpose of the role is to ensure all trial activity conducted through the KCTU meets the highest standards and complies with the relevant internal SOPs, regulatory policies and procedures.

This post will be offered on an indefinite contract

This is a full-time post - % full time equivalent

Key responsibilities

  • Delivery of the QA function within the KCTU
  • Provide input into the KCTU wide programme of continuous improvement and further development
  • Have a good understanding of the requirements of a Quality Assurance Role and current regulations governing the conduct of trials as well as GCP
  • Represent QA at KCTU meetings
  • Represent KCTU at UKCRN CTU QA meetings
  • Host audits and inspections of KCTU
  • Any other duties appropriate to the grade as directed by the supervisors
  • The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.

    Skills, knowledge, and experience

  • Solid knowledge of MS Office, particularly Word, Excel and Outlook
  • Excellent organisational, written, verbal communication and interpretation skills as well as a strong capacity to troubleshoot
  • Experience of managing varied workloads and evidence of ability to prioritise own workload
  • Experience of explaining complex ideas in an appropriate format for academic and non-academic groups
  • Excellent written and verbal communication skills enabling effective communication with a range of clinical, academic and non-academic staff
  • Good attention to detail with the delivery of own workload and the review of others
  • Experience of maintaining confidentiality between groups/individuals, whilst promoting a collaborative working environment
  • Ability to produce appropriate standard operating procedures and implement them
  • Previous experience of working in an academic environment/Clinical Trials Unit within the Quality Assurance field
  • Able to identify broad trends and assess deep-rooted complex issues
  • Experience of MHRA inspections and other audits
  • Knowledge of computer system validation procedures relating to clinical trials
  • Proven track record or working collaboratively with a range of specialists including statisticians, pharmacists, health economists
  • Understanding of NHS and academic structures and their organisation
  • Essential criteria

  • A degree or equivalent extensive experience in either Quality Assurance and/or clinical trials
  • Extensive experience in the development and maintenance of quality management systems
  • Experience of advising and influencing at a senior level
  • Enthusiastic, motivated and capable of maintaining judgement whilst working under pressure
  • Methodical, practical, attention to detail
  • Ability to work to and meet firm deadlines
  • Ability to negotiate with academic and private stakeholders, resolving tensions where difficulties arise
  • Problem solving and using own initiative where appropriate
  • Able to plan and manage new major projects ensuring they complement broader KCTU strategy
  • Desire to maintain understanding in all fields relevant to the post including GCP, Clinical Trial Regulations, Data Protection, Quality Assurance etc.
  • Desirable criteria

  • An MSc in Clinical Trials or relevant postgraduate higher degree
  • Knowledge of Good Clinical Practice, Data Protection and the Medicines for Human Use (Clinical Trials) Regulations , Medical device legislation, Software as a medical device legislation
  • Desire to continue to develop skills
  • Willingness to travel

  • 3 days ago



    London, England

    £38,304 to £45,026 per annum, including London Weighting Allowance

    King's College London

    Permanent

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