- Unique CTA opportunity!
- Worthing, West Sussex (with extensive travel)
- Official title: Clinical Document Specialist
- Permanent position with competitive salary and benefits
- Leading Pharmaceutical company with exciting R&D pipeline
- Spend extended periods abroad (e.g. Germany, USA)
- Strong communication and organisation skills ESSENTIAL
- Understanding of SharePoint HIGHLY DESIRABLE
- Knowledge of clinical regulations (e.g. GCP) ESSENTIAL
Summary
A brand new permanent role has been created within a one of Europe’s most innovative and unique Pharmaceutical companies. Do you have some experience as a CTA, or similar experience related to clinical trial documentation? Do you have proficiency and experience in document and database management, preferably gained in a highly regulated Pharmaceutical / Clinical setting? We are looking for a highly organized individual with excellent communication skills, ideally with knowledge of SharePoint or advanced / superuser knowledge of a similar system. 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) on occasion. If you have a strong grounding in data and document management, backed with a good understanding of clinical trials and associated regulations (e.g. GCP, 21 CFR Part 11, GAMP, GMP), this is a truly unique and exciting career opportunity.
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 170 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.
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. 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.
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.
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.
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
- BUPA medical plan
- Annual bonus
- Appropriate expenses for international travel
Experience
The successful candidate will need to demonstrate very strong aptitude for Clinical Data / Document Management, 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.
Keywords
CTA, Clinical Data Administrator, Clinical Trials, Clinical Trial Administration, Documentation, SharePoint, Microsoft SharePoint, Administrator, Master File, TMF, Archiving, Microsoft, MS, Archivist, Life Science Graduate, Pharmaceutical Development, Drug Development, Germany, Munich, Spain, USA, GMP, GAMP, GCP, 21 CFR Part 11