Beschreibung
Qualifications:
*Bio-medical degree at university level.
*Long term experience in clinical trials
*Has a good knowledge of the clinical trial environment in Belgium, the Netherlands and Luxembourg including local laws, codes of conduct and policies
*Is strong in communication ensuring good customer relations both internally as well with external parties and government agencies
*Has leadership skills to ensure compliance with guidelines/SOP.
*Proficient in writing and speaking of the country languages and in English Active member of a professional development organisation in the field of clinical trials/quality management
Tasks and Responsibilities:
*Development and maintenance a quality management system for clinical trials
*Ensure development, implementation and maintenance of local procedures that can be used in both countries, taking into account country specific differences and synergies between countries
*Development and training in the area of international GCP regulations policies and SOPs and liaise with international training department
*Organising classical GC&OP training, E-learning and (re)certification exams and maintain training compliance records
*Maintain audit archive, act as point of contact for GCQA department and facilitate in preparation of corrective action plans.
*Discuss audit findings and implement action in order to avoid re-occurrence
*Preparing, conduct and outsource internal quality checks, report and feedback to department Prepare in house staff and site staff for regulatory inspections and coordinate inspections at sponsor site
*Support employees in the area of GCP, SOPs, policies and laws for the conduct of clinical trials, both national and international
*Maintenance of historic local SOP archive
*Support central company functions such as central GCP manager in terms of SOP development, global policies, templates and compliance