Many questions in healthcare are currently not sufficiently studied using clinical trials, despite their high societal importance. KCE concluded in the summer of 2015 that public funding of such trials would be beneficial ("Report 246-2015"), under certain conditions. These trials not only contribute to better patient care but also to a more efficient use of public resources.
The Minister of Health Maggie De Block decided in the fall of 2015 that KCE should start a programme of pragmatic and practice-oriented clinical trials. The available budget for the KCE Trials programme in 2016 and 2017 is €5 mio, increasing to €10 mio from 2018 onwards.
KCE will select and fund the trials. The trials are typically conducted by a non-commercial sponsor. Exceptionally, KCE will be the sponsor of a trial and work with a Contract Research Organisation (CRO).
In the context of the KCE Trials programme an expert (researcher) in clinical trials is sought.
For trials where KCE is the sponsor, the expert will outsource specific sponsor tasks to a CRO and/or non-commercial parties, coordinate all parties involved in the conduct of the trial (chief investigator team, recruiting sites, CRO, third party suppliers, …) and assure a high quality trial is completed on time and within the planned budget.
For KCE Trials where KCE is not the sponsor, the expert will prepare (with legal support) the trial contracts between KCE and the trial sponsor, and possibly third parties, possibly with local site visits and follow-up of the progress of trials including the payment schedule.
The expert will help organise CE Trials Prioritisation Group meetings, panel meetings and methodological trials board meetings as part of the trial selection process. The expert will assist in the development of a quality management system for the KCE Trials programme, and assist in the installation and use of software tools for the management of the KCE trials programme. From time to time international travel will be required.
Master’s degree (University diploma, minimum MSc level or equivalent).
Familiar with all aspects of multicentre randomised clinical trials (in particular pragmatic clinical trials) and an overall minimum experience of 9 years in various aspects of clinical trials. This can be at the side of the trial regulator, funder, sponsor or investigator. The field of clinical trials includes logistics, budget, interactions with regulators and third parties, centralised randomisation, development of eCRFs, monitoring and safety reporting, data management and statistical analysis, reporting and archiving, etc. Up to date knowledge of GCP and clinical trial regulations in Belgium. Familiar with the Belgian healthcare system and the reimbursement system.
Minimum 5 years of experience in outsourcing of clinical trials to CROs including the follow-up of the CROs.
Minimum 5 years of experience with managing contracts and payment schedules for clinical trials.
Ability to analyse results and generate reports using Word, Excel, prepare presentations in PowerPoint, able to work with versions control in documents.
- English: very proficient in written and spoken English
- Dutch: fluent
- French: fluent
Knowledge of other languages is a plus.
What we offer:
We offer a permanent employment contract in a challenging, innovative environment where personal development and growth are encouraged. An attractive remuneration package with benefits such as meal vouchers, medical insurance, group insurance, reimbursement of public transport (home-workplace) or cycling allowance. Home working is possible from time to time.
Send your CV in English with a motivation letter in English to jobs[at]kce.fgov.be before Monday June 12th, 1pm.
If you meet all requirements, you will be invited for an oral interview (mainly in English, but also in French and Dutch) which will be held on either Tuesday 20th June (afternoon) or Tuesday 27th June (all day). There may be additional tests after these dates for the final candidates.
Need more information about the content of the job?
For KCE Trials related questions contact Frank Hulstaert,
frank.hulstaert[at]kce.fgov.be, tel. +32 2 287 33 73
For HR related question contact Miranda Landtsheere
You find more information of KCE on www.kce.fgov.be