A well-known global pharmaceutical company with leading products across various therapeutic areas is looking to hire a Clinical Process Manager to join their team in Brussels, Belgium. This vacancy is an exciting opportunity to work at a top global pharmaceutical company that has a workforce of more than 6,700 employees across multiple sites in the UK.
The Clinical Process Manager position for NLBE supports the SMM function in both Netherlands and Belgium and the related staff. The Clinical Process Manager is responsible for the maintenance and further development, and the communication of high quality standards in the delivery of clinical studies. This includes a key role in ensuring that the training needs in the local SM&M (Site Management & Monitoring) team are fulfilled in cooperation with the local SM&M leadership team.
- Provides compliance and process advice to their local SM&M team and identifies opportunities for quality and process improvements on local, regional and global level.
- Responsible for the development, implementation and continuing review of local procedural documents, and maintains current knowledge and understanding of local regulations and industry practices in relation to clinical trials.
- Supports audits and inspections and is the main contact for auditors for the local SM&M team.
- Supports the local SM&M leadership team in the planning and implementation of all quality control activities and uses risk management to evaluate compliance issues and develop solutions.
- Keeps abreast of any business compliance issues and works in close collaboration with key regional and global networks.
- May take on additional responsibilities or other roles such as local study team leader or line manager, or key global/regional assignments as agreed with local and/or regional SM&M leadership.
- May provide support to the Medical team in the Marketing Company in relation to conducting regional and local Non-Interventional Studies (NIS) or Investigator Sponsored Studies (ISS), or Pharmacovigilance, which are within the scope of CPrMs Job Description, and as agreed with local SM&M Leadership.
Education, Skills and Experience:
- University degree in related discipline, preferably in life science, or equivalent.
- Fluent knowledge of spoken and written English, and Dutch/Flemish and preferably in French.
- At least 5 years' experience in the pharmaceutical industry, preferably in Clinical Development/ Quality Assurance
- Good understanding of the drug development process and related GXP activities
- Good understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g. ICH-GCP, study management, site management, monitoring
- Good knowledge of local and international regulations and guidelines, as well as company Procedural Framework
- Ability to interact widely and effectively within the company at all levels
- Ability to work in an environment of remote collaborators.
- Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- Excellent written and verbal communication skills
- Ability to travel nationally (Belgium and Netherlands) and internationally as required.
- Valid driving license
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Maartje Ramakers on +44 207 4400 632 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.