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Clinical Study Manager - Belgium  

ASIT Biotech (company)


Posted on : 01 December 2016

Project Description

1 Clinical Study Manager 20160615 Job Description.docx Clinical Study Manager Scope of the responsibility: In a metrical setting, the Study Manager will support the Project Manager and the Project Leader in all operational daily activities. Job description Operational input on study key documents (protocol, CRF and eCRF, diary cards, monitoring guidelines, data management documents, tracking log, coding list and all other study related document) Support the preparation of all the key documents required for a submission to EC or MOH Support the preparation on and organization of Study specific training such as Monitors training or Investigators meeting /refreshers Organize the sites supplies with study materiel including IMPs Ensures and maintains adequate study medication supplies to the sites Set-up and maintain eTMF (define key documents collection according to study milestones) Contribute in study team meeting (conducted with CROs), organize the meeting/TC details and take the minutes and action log Training of the CRO staff on the product, the indication and the study protocol, to provide a scientific support to the CRO Perform remote monitoring to ensure study data is adequately recorded in eCRF and quality of the monitoring actives are as per defined Track and communicate to the study team on the overall study progress (for example patient enrolment rate, AE/SAE listings ) Support of department activities as required. Education and Skills Bachelor, Master in scientific field Minimum of 2 years previous experience in pharmaceutical industry, preferably as CRA Excellent knowledge of ICH-GCP Excellent capacity using IT office tools Master soft skills Fluency in English and French Excellent organizational and time management skills 2 Clinical Study Manager 20160615 Job Description.docx Team spirit and teamwork ability Adaptability to a changing environment Presentation skills Past experience in immunotherapy for Allergy is an asset, enthusiasm is a must Applicants should send their CV to: Mr. Albert Vicaire (albert.vicaire@biotech.be) with reference to Clinical study manager application . About ASIT biotech ASIT biotech is a Belgian clinical stage biopharmaceutical company focused on the development and future commercialisation of a range of breakthrough immunotherapy products for the treatment of allergies. Thanks to its innovative ASIT+TM technology platform, ASIT biotech is currently the only developer of AIT product candidates consisting of a unique mixture of highly purified natural allergen fragments in an optimal size selection. This innovation results in a short treatment, expected to improve patient compliance and real-life effectiveness. ASIT biotechs product pipeline entails two novel ASIT+ product candidates targeting respiratory allergy with the highest prevalence (i.e. grass pollen: gp-ASIT+TM and house dust mite: hdm-ASIT+TM), that could significantly expand the current immunotherapy market. The Company believes that its innovative ASIT+ platform is flexible and would be applicable across a range of allergies. gp-ASIT+TM, our product candidate for the treatment of grass pollen rhinitis consists of a mixture of natural allergen fragments obtained from a purified specific proteinic extract from Lolium perenne pollen. In contrast to the synthetized peptides, the natural peptides (70% of the fragments ranging from 1,000

Locations

Woluwe-Saint-Lambert, Brussels, Belgium

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