Isabelle De Bock Email & Phone Number

Mechelen, Be

Wilrijk

The Clinical Division of the QbD group is an expert clinical solutions provider specialized in Medical Devices, IVD & Biotech. QbD Clinical offers on a global level support in the following areas:- Flexible Clinical Staffing Solutions- Full-Service and tailored CRO solutions including Clinical Operations, Clinical Regulatory, Clinical Quality & Biometrics- Medical Writing- Clinical Evidence Strategies- Medical Affairs- Performance Evaluation StudiesPlease… Show more The Clinical Division of the QbD group is an expert clinical solutions provider specialized in Medical Devices, IVD & Biotech. QbD Clinical offers on a global level support in the following areas:- Flexible Clinical Staffing Solutions- Full-Service and tailored CRO solutions including Clinical Operations, Clinical Regulatory, Clinical Quality & Biometrics- Medical Writing- Clinical Evidence Strategies- Medical Affairs- Performance Evaluation StudiesPlease visit www.qbdgroup.com/clinical or contact us at info.clinical@qbdgroup.com Show less

Wilrijk

QbD Clinical (member of the QbD Group and formerly known as TRIUM) offers on a global level:- Flexible Clinical Staffing Solutions&- Full-service and tailored CRO Solutions:o Medical Device experto Clinical Operationso Biometricso Medical writingo Clinical Regulatoryo Safetyo Quality Assuranceo Trainingo Medical AffairsPlease visit www.qbdgroup.com/clinical or contact us at info.clinical@qbdgroup.com

Lier, Belgium

Lier

Brussels Area, Belgium

Brussels

Brussels Area, Belgium

Brussels Area, Belgium

Diegem

Global compliance lead for Clinical Research departments at Bridgewater (US) and Diegem (EU):- SOP maintenance inlcuding periodic review & gap analysis- Inspection readiness activities & internal audit support- Design & development of training curricula including identification of training gaps & organization of departmental trainings- Ad hoc study team support & input with focus on ISO 14155:2011 compliance- Drive quarterly departmental protocol deviation &… Show more Global compliance lead for Clinical Research departments at Bridgewater (US) and Diegem (EU):- SOP maintenance inlcuding periodic review & gap analysis- Inspection readiness activities & internal audit support- Design & development of training curricula including identification of training gaps & organization of departmental trainings- Ad hoc study team support & input with focus on ISO 14155:2011 compliance- Drive quarterly departmental protocol deviation & non-compliance meetings- Clinical POC for Regulatory department in EMEA and BIMO department, Complaint Handling department, Quality Training department & Product Lifecycle Management team in US- Support vendor qualification processes such as Health Care Compliance Due Diligence, Business Partner Risk Assessment, Bioresearch Monitoring & Software Quality Control audits- Member of global J&J MD&D Clinical Research Excellence Team- Line management Show less

-Quality Control of study files-Support regulatory readiness & departmental compliance meetings-SOP writing & review -Member of several task forces (compliance, filing, safety)-Coordination & development of tools and documents to standardize & harmonize monitoring processes

Project & CRA management:- Scientific writing & review (protocol, ICF, CRF, presentations) - Coordinate development of Safety management Plan, CEC charter, Monitoring Plan & Data management Plan- Drive EDC set-up & UAT testing - Coordination of EC submissions & site initiation/monitoring visits- Support organization of & present at Investigator Meetings - Responsible for ensuring overall study compliance (including Health Care Compliance) & timely and accurate event… Show more Project & CRA management:- Scientific writing & review (protocol, ICF, CRF, presentations) - Coordinate development of Safety management Plan, CEC charter, Monitoring Plan & Data management Plan- Drive EDC set-up & UAT testing - Coordination of EC submissions & site initiation/monitoring visits- Support organization of & present at Investigator Meetings - Responsible for ensuring overall study compliance (including Health Care Compliance) & timely and accurate event reporting- Support selection & contracting of external vendors + responsible for managing EDC, data management & safety vendors (including budget control & CEC/DSMB set-up)- Review monitoring visit reports & line/resource management CRAs- Central point of contact at Sponsor for site management vendor Show less

1) Project & CRA management (2007-2008):- Protocol & ICF writing and coordination of review, finalization and QA approval- Develop paper CRF & completion instructions and drive finalization, printing & distribution- Coordinate contract negotiations (HCC compliant) & site payments- Coordinate EC/CA submissions & insurance set-up- Organize and present at Investigator Meetings & CRA training- CRA management (5 in total) & review of monitoring visit reports- Support &… Show more 1) Project & CRA management (2007-2008):- Protocol & ICF writing and coordination of review, finalization and QA approval- Develop paper CRF & completion instructions and drive finalization, printing & distribution- Coordinate contract negotiations (HCC compliant) & site payments- Coordinate EC/CA submissions & insurance set-up- Organize and present at Investigator Meetings & CRA training- CRA management (5 in total) & review of monitoring visit reports- Support & conduct Site Selection, Site Initiation, and (co-) Monitoring Visits- Responsible for managing external vendors (data management, monitoring)- Responsible for ensuring study compliance & timely adverse event reporting- Coordination of data collection2) Monitoring (2005-2007): Conducting monitoring visits and performing site management for several drug-eluting stent studies in an international environment Show less

Jan 2003 to Dec 2003: in-house support for datamanagement groupDec 2003 to Jul 2005: Outsourced to Cordis as CRA (both in-house as field monitor)

Master, Biology (Physiology)

Graduated with highest distinction

Teacher'S Degree

Master, Neurology / Physiology

Activities and Societies: FWO scholarship (Fonds voor Wetenschappelijk onderzoek / Research Foundation Flanders)

Latin-Mathematics (8H)