Description
One of our client, a multinational pharmaceutical company, currently requires a Clinical Scientist
Location: South of Brussels
Duration: 18 months
Start date: ASAP
KEY RESPONSIBILITIES
* Support the Clinical Development Manager in effective implementation of Clinical
Development Plan for day to day interaction with, clinical operations LOCs, study centers,
external partners, preparation and follow-up of IDMC, trial steering committees, advisory
committees, monitors and investigators meetings;
* Support the CDM in day to day medical monitoring of the study (adverse events follow-up,
MEDRA coding, follow-up with pharmacovigilance for SAEs );
* Coordination of implementation of regional/global studies (CRTs) and Onco-RD studies in
close collaboration with clinical operations;
* Contribute to development of briefing documents, regulatory dossiers, protocols, end of
study reports with scientific writer and CDM;
* Within the business unit, ensure dedicated project planning, tracking and executional
management across the clinical functions for specific projects (CDM, Biostat, SciWri, CSC,
Data Management);
* Monitors the clinical project in terms of milestones, ie proposes corrective actions to
CDM/Lead CDM by reviewing and incorporating input from Clinical Operations (both central
and regional) in terms of timing, feasibility, performance and availability of resources
* Actively participate in country/center selection process (in collaboration with clinical
operation and Lead CDM/CDM)
* Organizes and prepare study team meetings with CDM; actively participates in a variety of
meetings if his/her presence is required (eg Project Team, Logistics, etc); ensures that
effective meetings management practices are adopted for assigned CPT's.
* Ensures that progress and information circulation/sharing tools are developed in a
harmonized manner amongst study team members
PREREQUISITES
Education : PhD in sciences (Life Sciences preferably), pharmacist or equivalent experience - MD is OK
Knowledge :
* Excellent knowledge and understanding of Clinical Study Management roles and activities
* Advanced knowledge ICH-GCP.
* Excellent knowledge of written & spoken English.
* Excellent knowledge of medical terminology
Experience :
* At least 3 years experience in clinical study conduct in pharmaceutical industry
* Ideally 2 years experience in similar function (clinical management)
* Experience in a Matrix/multi-disciplinary environment
* Experience in clinical research with oncology products at an international level