Luc Coninx

In house consultant is a member of the Lean Management Change Team, acting as an internal consultant and change agent, playing a key role in supporting and providing guidance and training to different departments during their introduction and implementation of Lean Management.

Responsible to liaise with the Operational Excellence Change Team to ensure a smooth transition between the transformation and Continuous Improvement phase. Further supporting the Business Team when entering into the Continuous Improvement phase after the initial Lean Management Transformation. The Continuous Improvement mission is to ensure the Business Team autonomy and self-sustainability in applying the lean management principles and continuous improvement

Supervise/perform the controlling and evaluation of the quality of (source) data at clinical investigational sites and assessing performance of the CRAs and the clinical investigational sites involved in a clinical trial with respect to their compliance with trial protocol, applicable SOPs, regulations and ICH-GCP, and coordinates the provision of consultancy to the CRAs and clinical investigational site staff in order to improve compliance with trial protocol, applicable SOPs, regulations and ICH-GCP.

Representing Head of Clinical Operations (staff 45-50) within the Global Development Operations department.

Managing a group of 15 CRAs.

Preparation/coordination of international clinical trials Phase I-IV, leading international multidisciplinary study team(s), planning/controlling of study budget/timelines, organization of logistics of clinical trials in cooperation with internal and external partners

Set-up, organization, coordination & management of central laboratory activities in worldwide clinical studies for international pharmaceutical companies

Management of European clinical studies with a medical device for pathogen inactivation of blood platelet concentrates for transfusion

• Day-to-day management of European Neuroscience Department reporting directly to the V.P. Clinical Research Europe [08/1996 – 08/1998 - due to vacancy of Departmental Director] • European project coordination of antidepressant and anti-parkinsonian compounds. • Activities including protocol design/review, CRF design/review/printing, Central Lab organization, Investigator meeting organization/presentations, Study progress/budget coordination, and Data/study report review for pan-European trials.

• European project coordination of antidepressant, anti-migraine and analgesic compounds • European coordination of safety (AE-SAE) reporting (review/follow-up) on CNS compounds. • Activities including protocol design/review, CRF design/review/printing, Central Lab organization, Investigator meeting organization/presentations, Study progress/budget coordination, and Data/study report review for pan-European trials. • Training of new CRAs

• Organization, monitoring, and report writing of international phase I - III clinical trials (Europe) with CNS drugs in compliance with FDA regulations, international GCP guidelines and internal Standard Operating Procedures. • Training of new CNS CRAs.

Scientific information on and sales of hormone and allergen radioimmunoassays, ELISA-, and immuno fluorescent assays/kits to commercial laboratories.

Comparative Physiology - Immunology