Clinical Project Manager

15/06/20

Location

Rue de Namur 73D Bruxelles Belgium

Function type

full-time

Vacancy

ABOUT US:

For nearly 15 years, the largest laboratories in the world have been showing their confidence in our company. Specialized in pharma, biotech and medical devices, we support our customers from research to product launch.

 

We cultivate a human-scale company spirit that allows us to personally follow our 430 employees – each of them known for their technical and scientific expertise. Through our regional subsidiaries in France, Belgium and Switzerland, we offer everyone geographical stability, without a mobility clause in the contracts. 


JOB DESCRIPTION:

CONSULTYS BENELUX is looking for a Clinical Project Manager to reinforce its Consulting team. As a consultant you will bring your expertise to our customer team. For these particular projects, the main objectives are: 

 

  • The Clinical Research Project Manager will be the key contact point for the whole organization regarding the preparation, set-up and follow-up of clinical investigations

  • Management of internal representatives (Project managers, R&D directors, ..) as well as suppliers (CRO’s, clinical partners)

  • Act as a subject matter expert for clinical investigations, to ensure clinical investigations are carried out according to regulatory requirements, ISO 14155 and QMS

  • Review current QMS, identify gaps and amend/implement necessary QMS processes to allow for clinical investigations

  • Align and inform relevant departments on potential clinical investigations Select CRO appropriate for the clinical investigation following supplier approval process

  • Review and approve clinical investigation documents such as, but not limited to, protocol, statistical analysis, study reports 

  • Submit necessary documentation to competent authorities and ethic committees for approval of clinical investigations

  • Report adverse events to appropriate competent authorities when necessary

  • Follow-clinical investigations with the help of a CRO

  • Support external audits from regulatory bodies regarding clinical investigation aspects

  • Ensure clinical investigations are properly monitored (site visits or CRO audit)  

  • Provide clinical investigation input for the Clinical Evaluation report 

 

START DATE: asap

WORK LOCATION: Walloon Brabant, Belgium, plus occasional travelling 

 

ABOUT YOU:  

  • Higher academic degree (MSc or PhD) in Life science  

  • 5-10 years of experience  

  • Knowledge of Medical device environment, clinical investigations and/or cell therapy 

  • ISO13485 & ISO 14155 experience 

  • High level computer literacy; including MS Office, SharePoint, Flowcharting software, Acrobat,… 

  • Adaptable and willing to take on multiple new tasks and responsibilities 

  • Independent collaborative self-starter with the ability to make appropriate quality-related decisions in real time 

  • Process oriented, logical, analytical, meticulous, highly organized and able to analyze data & implement solutions 

  • Willingness to travel 

  • Excellent high level oral & written communications skills in English & French enabling incumbent to act as a facilitator and / or educator with strong leadership skills 

 

Do you want to integrate the consulting world into a human-sized company that values the individual and the performance? Do you want to invest in long-term innovative projects? To share your skills in a close-knit team where experiences are shared freely? So, join us! We offer you an attractive salary and fringe benefits. You will work in a stimulating international environment, with numerous opportunities for personal development.

Job application