Expert in Clinical Trials

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Background

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 (KCE Trials programme). 
KCE will select and fund the trials. The trials are typically conducted by a non-commercial sponsor. 
In the context of the KCE Trials programme an expert (researcher) in clinical trials is sought.

Tasks

The Expert will be responsible for representing the funder, organise calls for trial proposals, the selection meetings and accompanying these trial proposals from the early stages of the selection process to when they are recommended for funding (understanding the operational set-up, agreement of budget and contract drafting) through start up and study performance to reporting and publication. They will interact closely with the Sponsor team and draw on support from other members of the KCE Trials team and KCE (clinical, statistical and health economics support). 

This may involve preparing (with legal support) the trial contracts between KCE and the trial sponsor, and possibly third parties, possibly with local site visits, managing the global budget and follow-up of the progress of trials including the payment schedule.

The expert will play an active part in other aspects of the KCE Trials programme for example helping organise 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. 

Requirements:

Master’s degree (University diploma, minimum MSc level or equivalent).

Candidates should globally have 9 years of relevant experience which can be from any of the following: project management, clinical trials, clinical research, research coordination, or working for a science or medical funder. You should have a minimum of either 5 years clinical trials experience or 5 years working for a science or medical funder. Familiarity with all aspects of multicentre randomised clinical trials (in particular pragmatic clinical trials) is an asset. 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. 

Ability to analyse results and generate reports using Word, Excel, prepare presentations in PowerPoint, able to work with versions control in documents. 

Candidates with a diploma obtained abroad should provide a certificate of equivalence.

Language skills:

You should be fluent in one of the national languages (Dutch or French) it is considered an asset if you have a good knowledge of the other national language. Additionally knowledge of English is considered a bonus taking into account the international and scientific context of KCE and KCE Trials.

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. After the first six month of employment you can work from home from time to time.

Interested?

Send your CV in English with a motivation letter in English to Trials[at]kce.fgov.be before Friday December 7th, 1pm.

Procedure

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 Friday 14th December  (afternoon), 18th December (afternoon), 19th December (afternoon) or Thursday20th December (morning). There may be additional tests or a second interview after these dates for the final candidates (likely early in January 2019).

Need more information about the content of the job?

For KCE Trials related questions contact Rasma Kass, 
rasma.kass[at]kce.fgov.be, tel. +32 2 287 33 57 

For HR related question contact Miranda Landtsheere
miranda.landtsheere@kce.fgov.be, tel. +32 2 287 3319 

You find more information of KCE on www.kce.fgov.be 
 

CONTACT
Miranda LANDSTHEERE
02 287 33 19
ANNUAL REPORT
Published on: 
2018/11/23