Birgen Meuleman Email & Phone Number

Antwerp, Be

Antwerp Area, Belgium

2 Bridge is a Belgian based company that provides scientific support, project leadership and due diligence services for pharmaceutical and health product development and production. More information: www.2bridge.be

Mechelen, Antwerp Area, Belgium

ELANDD = Enhance Life by Advancing Novel Drug Development

Turnhout, Belgium

Tasks:- Accountable responsible for the planning, implementation en execution of a global clinical research project with a novel treatment for patients suffering from GORD, Gastro-Oesophageal Reflux Disease in 100 medical sites in 10 countries (US & Europe).- Chair an international multidisciplinary project team to lead the day-to-day management of the trial by implementing clear reporting tools, deliverables and timelines.- Negotiate contracts and effective monitor budgets (in total 20M€) of 15 external partners (Clinical Service Organisations, Laboratories, Advertisers, Event organizers, etc.)- Organize face-to-face en virtual Investigator Meetings and impose ad-hoc quality audits at participating physicians en partners to safeguard the integrity of collected research data.- Report of study progression to the leadership team and advice on operational aspects and the implementation of the Drug Development Program.Cross Functional Activities:- Coaching junior Clinical Program Managers.- Volunteer to various interdepartmental working groups to enhance electronic systems and to optimize procedures.- Nominated representative of the Shire-Movetis employees during the negotiation of the social plan (i.e. severance pay, notice period, outplacement, etc) due to collective dismissal and business closure by Shire.

Mechelen & Beerse, Belgium

Lead Global Trial Manager, Senior Manager GCO Infectious Diseases & Vaccines (May'10-Jun'11)Clinical Trial Leader (Manager Global Clinical Research (Feb'08-May'10)Tasks:- Ensure the efficient and flawless planning, implementation and execution of a global pivotal trial in Hepatitis C (virology) in 110 research centres in 17 countries (North and South America, Europe, Australia).- Lead and motivate the global Clinical Trial Team towards a timely completion of the project to guarantee an accelerated FDA/EMA filing of the first novel drug for the treatment of Hepatitis C in 25 years.- Co-operate with internal Quality Assurance Team during FDA en EMA inspections as well as being the direct spokesman for operational related questions of the FDA investigator in the inspection front room.Cross Functional Activities:- Business unit representative in selection and recruitment of candidateClinical Trial Assistants and Global Trial Managers.- Departmental primary contact person to liaise with the preferred central lab provider.

Brussels, Belgium

Tasks:- Responsible for day-to-day management of various international clinical research projects in haematology, oncology en plastic surgery.- Support Business Development in preparing cost proposals and participate in bid defences at clients within the pharmaceutical industry.- Execute performance reviews of team members.Cross Functional Activities:- Liaison with external ICT consultant. Organize end user IT trainings (Outlook, Excel, Word, PowerPoint) and create user friendly IT manual.- Administrator for set-up of trials in central database system (TrialWorks/CTMS)

Brussels, Belgium

Tasks:- Responsible for monitoring medical centres in Belgium, The Netherlands and France participating in clinical trials in the domain of gastroenterology, haematology, rheumatology and plastic surgery.- Submit clinical trial applications to ethics committees and competent authorities. Resolve annotations until full dossier approval.

Antwerp, Belgium

Animal Behaviour; PrimatologyTasks:- Independent research in stress behaviour and stress physiology in bonobos (Pan paniscus).- Present results in international journals and at conferences.- Teach the optional course Primatology and practicals in Animal Behaviour. Support thesis students and trainees.- Produce educational presentations for a broad non-scientific public.

Göttingen, Germany

Physiology; Endocrinology(6 months in total)Tasks:- Conduct endocrinological analyses (hydrolyses, extractions, E.I.A., etc.).- Process and interprete hormonal

Master, Biology

Education record

Education record