Quality Officer - Maternity Cover
Locations: Sidcup - Kent / Romford - London
Salary: £25,000 - £28,000
Are you looking for an outstanding opportunity to develop your career with a leading edge Commercial Clinical Trials company which is growing fast? MeDiNova Research concentrates on quick patient recruitment, high data standards and delivering an excellent patient experience resulting in a high level of patient retention. These qualities are what our Sponsors look for in a leading Dedicated Clinical Research Organisation and you can be part of our success story.
We are growing our international footprint and you can play a part in our expansion and be involved in the future of medicine across the globe and have an exciting opportunity for a Quality Officer (maternity cover) to join our team.
Supporting the Senior Director - Quality Assurance and Senior Quality Officer, the Quality Officer is required to work in conjunction with the other Quality Officers. The key responsibilities of this role are to execute an operational quality framework within the regional (UK) business.
The main responsibilities for this great opportunity are:
- Performing quality checks on all aspects of the clinical research activities performed at MeDiNova sites and associated documentation.
- Investigating and classifying reported Quality Issues.
- Facilitation of root cause analysis sessions.
- Development and implementation of corrective and preventative action plans in conjunction with site staff.
- To drive and deliver operational quality and process improvement initiatives, training and compliance across the sites to increase operational quality, efficiency and long-term business success.
- Provide consultation on operational quality, risk and regulatory and legislative compliance.
- Work with MeDiNova personnel to improve and implement globally working practices and systems, in compliance with GCP and appropriate regulations to ensure best practices are achieved.
- Be part of the Quality team and assist the business, the culture, the values and the wellbeing of the employees and the company in all areas.
- Provide support to external client audits and regulatory inspections.
- Be required to travel to sites as directed by Senior Director of Quality.
The ideal candidate for the role will also have the following skills/experience:
- Minimum 1 years’ experience in a Clinical research role within a Site Management Organisation, Clinical Research Organisation or Pharmaceutical business.
- Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.Knowledge of maintaining and improving quality systems and procedures.
- Prior experience in a Quality role within clinical research ideally with knowledge of performing Quality checks or audits of data.
- Exposure to client audits and regulatory inspections, ideally in a Quality role.
- A demonstrated commitment to quality in a regulated environment.
- Ability to work independently, with minimal supervision, and be confident to make local decisions and escalate accordingly.
- Willingness to travel regionally on a regular basis.
- Exceptional customer services skills to both internal and external stakeholders.
- Preferably experience of preparing an analysing data and Quality Metrics.Knowledge of international GCP regulations and regulatory inspections.
Auto – enrolment company pension scheme
Life assurance (three times cover)
Incremental annual leave entitlement increase
Regular in-house training
Tax free bike scheme
Discretionary bonus scheme
About the Company
MeDiNova is a rapidly growing multi-national involved in the clinical trial space with 106 quality research centres across nine countries and three continents. We aim to be the patients’ choice for clinical research. Our team of highly trained and dedicated staff live the MeDiNova values of patient engagement, integrity, empowerment, customer service and expertise.