KCE recruits an Expert in Clinical Trials
Many questions in healthcare are currently not sufficiently studied using clinical trials, despite their high societal importance. The KCE concluded in the summer of 2015 that public funding of such trials would be beneficial ("KCE Report 246-2015"), under certain conditions. These trials not only contribute to a better care for the patient but also to a more efficient use of public means.
The Minister of Public 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.
The KCE will select and fund the trials but will not conduct the trials.
In the context of the new KCE Trials programme an expert in clinical trials is recruited.
- Develop and maintain a quality system including standard operating procedures (SOPs) for the KCE Trials programme, and assist in the instalment of a web based software tool for the management of this trials programme.
- Organise the KCE Trials Working Group meetings, the domain panel meetings and methodological trials board meetings as part of the trial selection process.
- Provide or coordinate advice to candidate trial sponsors, where needed and appropriate, on issues on regulatory issues, data management tools and eCRFs, study outsourcing, logistics, insurance, use of reimbursed procedures, intellectual property and international collaboration.
- Prepare (with legal support) the trial contracts between KCE and the trial sponsor, and possibly third parties, possibly with local site visits.
- Follow-up of the progress of the trials including the payment schedule, possibly with local site visits.
From time to time international travel in the context of international clinical trials.
- University diploma, minimum MSc level or equivalent.
- Familiar with all aspects of multicentre clinical trials and an overall minimum experience of 10 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, interactions with regulators and third parties, centralized randomization, development of eCRFs, monitoring and safety reporting, data management and statistical analysis, reporting and archiving, etc.
- Minimum of 5 years of experience developing/auditing quality systems/SOP for clinical trial funders/sponsors and up to date knowledge of GCP and clinical trial regulations in Belgium.
- Minimum 5 years of experience with contracts and payment schedules for clinical trials.
- Familiar with the Belgian healthcare system and the reimbursement schedules.
- Familiar with pragmatic practice-oriented trials.
- Ability to analyse results and generate reports using Word, Excel, prepare presentations in PowerPoint, able to work with tracked changes and versions control in documents.
1. English: very proficient in written English; fluent in spoken English.
2. Dutch: fluent
3. French: fluent
Knowledge of other languages is considered a plus..
Apply your CV in English with your motivation letter by email at email@example.com before 5th of February 12.00 a.m.
Need more information?
Contact Frank Hulstaert, senior researcher, firstname.lastname@example.org, tel. +32 2 287 33 73 and Nathalie Swartenbroeckx, project coordinator, Nathalie.email@example.com , tel. +32 2 287 33 24.
You find more information of KCE on www.kce.fgov.be