Quality Assurance & Compliance Director (EDDRP UK)

CANCER RESEARCH UK
London
England
2020-10-29T04:35:39Z

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Quality Assurance & Compliance Director

Location: London – Picadilly Circus or Stratford

Salary: commensurate with experience

Full time, 35 hours per week

Closing date: 8th November 2020

Please note that the employer for this role is EDDRP UK, not CRUK. This role is being advertised by CRUK on behalf of EDDRP UK. Applications will be reviewed by EDDRP UK.

You will be accountable to build and manage an effective and efficient Quality Management System (QMS) in a fast paced and busy start up environment.

Your role will be to work across EDDRP with particular emphasis on the Clinical Operations team, as they execute the recruitment strategy to deliver the ‘Accelerating Detection of Disease’ (ADD) programme.

The recruitment of participants into our research platform will occur across the 4 devolved UK nations and as such you must be familiar with working within complex matrix environments, where stakeholder expectations and compliance to regulatory and ethical procedures must always be maintained.

Key Responsibilities:

• Build and implement the Global Quality Management Plan ; this will include: planning and executing the Quality Management activities; risk identification and assessment through data review and quality control processes either remote or on site; providing support in risk mitigation, in planning corrective/preventive actions and guidance for improvement;
• Review Non-compliance & Deviation reports for accuracy, RCA and CAPA plans.
• Cooperate closely with the relevant Heads of business and other stakeholders, support maintaining focus on quality in project delivery. Contribute to the development and implementation of a Regional and/or Sponsor specific Quality Management Plan and Risk Management Program, monitor the implementation, and deliver.
• Provide advice and support to functional operational teams including regulatory reporting, medical information, endpoint adjudication and aggregate reporting.
• Work in close cooperation with operational teams to manage non-compliance, quality issues; assist in planning corrective/preventive actions, as applicable according to SOPs.
• Work closely with assigned business staff in case of suspected misconduct; as required by the applicable SOPs.
• Provide assistance during audits and regulatory inspections to the operational teams.
• Act as the primary contact for Quality Assurance on clinical quality matters – on the level of the assignment and attend meetings/teleconferences.
• Prepare periodic reports to the Chief of Staff and to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives.

Key Technical Skills, Knowledge, Experience and Behaviours

Essential:

• Bachelor’s degree in life sciences or equivalent, with a minimum of 6 years’ experience in Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management. Preferably with 2 of these years being in a related Quality position.
• Knowledge of relevant regulatory processes (e.g. ICH GCP, HTA training) and the UK clinical research trial environment
• Excellent working knowledge of medical terminology, clinical monitoring procedures (SOPs), ICH-GCP, applicable regulatory requirements, quality management processes
• Knowledge of National and International Regulations and Research Tissue Banking processes
• IT Literate with a good appreciation of Microsoft applications and databases, well-practiced in preparing management information and reports.
• Experience of third-party vendor management, able to demonstrate influencing skills and experience of negotiations
• Strong interpersonal skills with the ability to inspire effective teamwork and motivate members within a matrix system. Resolves conflict as needed.
• Ability to impart your specialist knowledge to others, for example run training sessions, in a constructive and meaningful way
• Must be able to thrive in a fast-paced, rapidly evolving environment with changing priorities.
• Highly motivated with a proactive approach to work.
• Excellent organisational skills, detailed orientated with the ability to multi-task
• Good judgement and decision-making skills
• Fluency in English language skills

Desirable:

• Experience of working in the pharmaceutical, charity or NHS sectors
• Understanding of population research and cohort studies.
• Risk management training.

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