MSc in Moleculaire Biologie en Biotechnologie
Arthur Goemaerelei 7/2, Antwerp
mobile phone: 0485/777.816
birth date: 17/05/1980
WHAT AM I SEEKING?
I’m looking for a coordinating function in the health sector. I want to use my research experience, obtained in the scientific and clinical sector, for more socially relevant themes. I’m searching for a varied job: manage and coordinate projects, generate ideas, consult, unsubscribe processes and procedures, compliance, implement actions and this all together with others.
WHO AM I?
Medical research is my passion. I’m strong in analysis and in designing and testing of innovative solutions. I love challenge and seek change. In everything I do, I strive for excellence. I quickly put ideas into actions, so I enthuse others. I notice problems and errors almost inevitably. This allows me to work proactively. I orient quickly from problem to solution. I feel at my best in a group, in which a similar goal is pursued and in which I can give my own opinion thought. I am good at building and maintaining in-depth contacts with people. I like to be appreciated for my accomplishments.
SOME MAJOR ACHIEVEMENTS
· When approaching the deadline of a very large clinical project, I had the opportunity to coordinate and the division of labour of this project successfully. In this intensive period I was able to coordinate the operation of a subgroup of about 10 colleagues. The action and training of new colleagues also belonged to my tasks, as well as follow-up emails, client communication.... The deadline was met and the customer was very satisfied with our services.
· During my time in the Netherlands, I worked with a colleague on a project. Despite our different functions and training, this intensive collaboration with my colleague went on an equal basis. The hypothesis of the project we had to disprove. The result was published in a scientific journal in 2011.
· Radioactive labeling of antibodies according to GMP guidelines is labor intensive. Therefore it was decided to automate this. During the last half year in Amsterdam I took care of the optimization of this process: the preliminary tests were carried out by me. Further automation is now in the hands of my successors.
Clinical Data Manager (DM)Mechelen, Belgium
Since October 2011
Clinical data manager
Clinical Data Manager bij SGS Life Science, Department Biometrics
Result: Data management of 3-4 clinical trials from start to end (fase I, II & III) (last 6 months as Study Data Manager for client)
- Establish clinical databases as STDM standards
- Establish and translation of clinical protocols in customer - friendly data capturing systems ( Rave & Inform )
- Review / analysis of clinical data with in-house defined front- and back-end checks, in collaboration with other colleagues
- Freezing / locking of clinical databases
- Work according to ICH GCP standards
- Interaction with clients (teleconferencing ) & colleagues
- Study Data Manager : responsible for all data management activities of CRO and vendors
Attention to detailAdaptabilityFlexibilityIndependenceCoordinationSelf-disciplineProblem solvingResponsibility
Biochemistry Cell biology Labtechnician Phase I R&DBiotechnologyClinical Data Management (CDM)Clinical trialsElectronic Data Capture (EDC) Good Manufacturing Practice (GMP)ICH GCP guidelinesMicrosoft ExcelMicrosoft Officemolecular biologyPre-clinical research Late Phase
Skills and Expertise
Analytical skills Create SOPs Use a confocal microscopyAdjust methodsAdjust processes and methods Control dataAdverse event reportingApprove queriesArchive study documentsArchive trial documentation and correspondence.Aseptic processingAseptic techniquesassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Attend investigator meetingCell cultureClinical data collectionCollaborate with project teamCommunicate effectively on different company levelsCommunicate with sponsorConduct research at universitiesCoordinationData codingData validationData verificationDesign case record form (CRF)Design database Develop and maintain GCP/ICH compliant processes which control the quality of work and clinical trials Ensure data consistencyInteract with CROsInteract with physiciansInteract with statisticiansMaintain strong relationshipsManufacture of non-GMP and GMP batchesmanaging a small teamOral presentationOversee data collectionPlan work to meet objectives and deadlinesResolves queriesReview exclusion criteriaReview informed consent processReview inclusion criteriaReview queriesReview study protocolsSerious Adverse Event (SAE) ReconciliationUse laboratory techniquesUse western blotting techniqueVerify dataWork with coordination and data management teams
Master in Molecular Biology and Biotechnology in Molecular Biology from University of Brussel in 2006
Industrial Engineer in Biochemistry from Karel de Grote hogeschool in 2003
Training and Certification
Time-management in 2014 Training
ICH GCP in 2011 Training
Werken met Radioactiviteit (level 4B) in 2010 Training
Werken met Radioactiviteit (level 5B) in 2007 Training
ICH GCP in 2011 Certification
Expert has 2 publications (Will be avalible with full profile)