- Clinical QA Document Controller
- Perfect for someone with GMP Document Control experience, looking for a new challenge
- Leading Pharmaceutical company with exciting R&D pipeline
- Spend extended periods abroad (e.g. Germany, Spain, Italy, USA)
- Excellent opportunity to develop your knowledge of clinical trials
- Strong communication and organisation skills ESSENTIAL
Summary
Do you have a background in Document Control within a Pharmaceutical / Medical setting? Do you have an understanding of GMP, GCP or similar regulations? Are you excited by the prospect of travelling to countries such as Germany, Spain, Italy and the USA? If you can answer YES!! to all three questions, then this will be an excellent career opportunity.
A brand new permanent role has been created within a one of Europe’s most innovative and unique Pharmaceutical companies. We are looking for a highly organised and confident individual with excellent communication skills, who is keen to learn more about clinical trials and take control of document processes to support international clinical drug trials. You will be based predominantly in Worthing, West Sussex, but must have the flexibility to spend periods of time (potentially a few months a year) at the company’s partner site in Germany, as well as travelling to other areas (e.g. USA, Spain, Italy) on occasion. If you have a strong grounding in data and document management, working to regulations such as GMP, GCP, GAMP, 21 CFR Part 11 etc (full training will be provided in all areas you have not covered before), this will be an excellent way to develop your expertise.
The Company
A pioneering European based Pharmaceutical company specialising in the development and sterile production of injectable and oral dose vaccines and diagnostic kits for people who suffer from allergies. They have developed an innovative approach to medical treatments over a number of decades and are in an exciting phase of expansion across Europe and the USA. There are around 270 employees in total in Worthing, with a similarly-sized partner site in Germany, and the company has an excellent reputation for its welcoming atmosphere, staff morale and ongoing career development. They have a number of ongoing clinical trials in different countries and have created this new position in order to empower someone with responsibility for compliance and control of clinical documents.
The Role
This is a broad and engaging role which requires a range of skills, as well as the willingness to travel to Germany, USA and other countries when needed. As a Clinical Document Administrator, you will work with key stakeholders across the business (including clinical and regulatory teams) to maintain and manage an intricate and complex range of clinical data and documents, in full compliance to industry regulations.
A big part of this role is to build strong, collaborative relationships with international teams and learn about the intricacies of the company’s clinical trial activities, so that you can become a main point of contact for the processing of clinical trial related documents. The fact that this role requires extensive travel illustrates the company’s culture for having the best possible partnerships between stakeholders, gained through face-to-face contact. Therefore, we require someone with a warm personality and the ability to engage people at all levels.
You will act as Administrator to the company’s document management systems (currently SharePoint) to secure access control and maintain updated SOPs. You will keep abreast of the progress of clinical study programmes and any updates to ICH GCP and other regulatory requirements, in order to identify areas to maximise efficiency in the processing, storage and retrieval of clinical information. You will ensure that all relevant documents and files are correctly named, uploaded, version controlled and “filed” appropriately, to enable rapid document retrieval. If you identify any discrepancies in these files, it will be your responsibility to query and investigate these files, so that you can be sure that everything is 100% accurate, as well as compliant to appropriate regulations.
Full details, including a comprehensive job description, will be provided on application.
Benefits
In addition to a competitive salary (negotiable depending on experience), the company offers a very good benefits package including:
- 25 days’ holiday
- Stakeholder pension plan
- Life insurance scheme
- Long term disability scheme
- Private medical plan
- Annual bonus (discretionary and non-contractual)
- Appropriate expenses for international travel (accommodation and travel costs)
Experience
The successful candidate will need to demonstrate very strong aptitude for Document Control, with experience ideally gained in a commercial Pharmaceutical / Clinical (e.g. CRO) setting. You must have the flexibility to be based primarily in Worthing, West Sussex, but spend extended periods (weeks or months) in Munich, Germany, as well as visiting other sites countries such as Spain and USA.
You will ideally have strong experience of document management platforms; and additional experience in Microsoft SharePoint (superuser level preferred) would be ideal. You will need to provide strong examples of your attention to detail, organised nature and ability to notice and investigate discrepancies. Above all else, we are looking for an engaging candidate with excellent communication skills and a desire to develop a career in the clinical trial sector.