Experience

Vitaz

• Belgium
• Hospitals and Health Care
• 200 - 300 Employee

• Study Coordinator Oncology

  • Jan 2019 - Present



UZA

• Belgium
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Study Coordinator Cardiology

  • Feb 2016 - Jan 2018

  - Coordination of conduct of clinical cardiology trials:° Development of a subject recruitment plan° Screening of patients and assisting with the informed consent process° Development of study specific tools to assist in protocol implementation° Planning of study specific visits and procedures° Supplying and maintaining essential documents and materials° Assisting with investigational product accountability and disposition° Data collection from patient medical files and during trial visits, procedures and phone calls° Input of study data in (electronic) case report forms ((e)CRFs)° Resolution of queries° Reporting and follow-up of (serious) adverse events ((S)AEs)° Assisting with submission of essential documents to the ethics committee° Follow-up on protocol non-compliance° Informing and updating sponsor on study progress° Organisation and planning of sponsor visits- Coordination of start-up of clinical cardiology trials:° Review of clinical trial documents: protocol, contract, ...° Assisting with preparing and submitting all documentation required for ethics committee submission° Management of scientific and financial/logistic approval of the clinical study at the site° Organisation and planning of pre-study visits and initiation meetings- Be the link between investigator and sponsor (research organisation/pharmaceutical industry/medical device industry)- Be the contact person for practical and administrative questions of patients, investigators, sponsors (research organisations/pharmaceutical industry/medical device industry), ethics committee, ...- Collaborate with nurses and medical technologists of the cardiology department- Attend meetings and give presentations

• Medical Technologist Cardiology

  • Nov 2008 - Jan 2018

  - Heart catheterisation lab: ° Technical support of invasive examinations and interventions of the heart and coronary arteries° Analysis and image processing of fluoroscopy images: measurement of left ventricle ejection fraction and stenosis quantification- CT scan:° Technical support and image processing of CT scans of the heart and coronary arteries- Collaborate to clinical studies and scientific projects- Explain procedures to students and other employees and train new colleagues - Work in a multidisciplinary team of doctors, nurses, medical technologists and medical office assistants- Attend trainings and keep up to date:° Anatomy, physiology and pathology of the heart and coronary arteries° Radioprotection° Basic life support (BLS)° Hygiene and sterility° Professional communication with patients and their family° Rights and duties of patients



The Janssen Pharmaceutical Companies of Johnson & Johnson

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Clinical Data Manager

  • Nov 2006 - Nov 2008

  Data cleaning of clinical subject database, which means: ° Review of (electronic) case report forms ((e)CRF) ° User acceptance testing of eCRF ° Quality control of eCRF migration ° Defining and validating the cleaning package of a clinical trial (by edit checks/listings) ° Check clinical database on inconsistent, missing and incorrect data ° Generate queries towards the sites in order to get the data clean ° Coding of medications and medical events ° Communications with all involved parties ° Overall responsibility to deliver a complete, accurate and consistent clinical database to the statisticians



Valesta E.U.

• Clinical Data Manager

  • Nov 2006 - Nov 2008

  Outsourced by Valesta to J&J Global Clinical Operations, Integrated Data Services (a division of Janssen Pharmaceutica NV) as associate CDM in clinical oncology trials. Outsourced by Valesta to J&J Global Clinical Operations, Integrated Data Services (a division of Janssen Pharmaceutica NV) as associate CDM in clinical oncology trials.