Bieke Peeters
Herent
Summary
Over 18 years working in Clinical Research with experience in Project Management, Lead CRA, and Clinical Monitoring as Site Manager in multinational studies (phases I - and IV). Significant experience working in Immunology, Oncology, Open Angle Glaucoma, Cardiology, Gastroenterology, Hematology, Anesthesiology and Osteoporosis Responsibilities have spanned the full duration of studies, from protocol development to final analysis. SPECIALTIES Project management and achieving project deliverables at the global level Coordinating cross-functional teams and facilitating effective communications between stakeholders. Strong organizational skills Alerting management to any serious quality issues. Milestone driven goal-oriented approach
Overview
22
22
years of professional experience
Work History
Senior Global Trial Leader Medical Affairs Delivery Unit
J&J Innovative Medicine( Former Janssen Farmaceutica)
07.2020 - Current
- Responsible for leading the cross functional trial team to develop the operational plan and end to end trial coordination
- Responsible for ensuring quality, timely oversight, and efficient execution of Janssen trials in compliance with Health authority regulations and guidelines and operating procedures and processes according to business needs within budget
- Accountable for trial delivery, budget, quality and milestones
- Participate in process improvement at trial levels
- Vendor Management: providing strategic and operational leadership to CRO and vendors
- Ensure employee engagement, inclusion and Credo behavior
- Managed an outsourced interventional Phase IV trial and end to end responsibility
- Developed and implemented strategies to improve team performance and productivity.
- Provided guidance and support to team members on operational
- issues.
- Fostered a positive work environment by recognizing individual achievements.
Clinical Project Manager start up Ophthalmology (Istar)
FirstWave Clinical Consultancy
10.2018 - 07.2020
- Responsible for leading the trial team to develop the operational plan and end to end trial coordination
- Responsible for providing strategic and operational leadership to Country Clinical Monitoring Managers in their assigned area
- Responsible for ensuring quality, timely oversight, and efficient execution of trials within their area, required regulations, and business needs, reporting to VP Clinical and regulatory
- Responsible for 3 Trials in APAC and Latin America
- Performed Due diligence activities for potential investors
- Provided required Trial information for IDE FDA study and CE mark file
- Performed periodic data analysis and incorporated improvements for Data Quality.
Clinical Project Manager Medical Devices (Terumo Europe)
04.2017 - 04.2018
- Responsible for leading the trial team to develop the operational plan and end to end trial coordination including vendor management and vendor selection
- Responsible for providing strategic and operational leadership to Country Clinical Monitoring Managers in their assigned area
- Responsible for ensuring quality, timely oversight, and efficient execution of trials within their area, required regulations, and business needs
- Managed multinational Global First in Human trials in Superficial Femoral or Popliteal Artery stenosis, and carotid stenting
- Mentoring local CRA’s and CRO CRA’s
- Performed case attendance requiring High Clinical and Therapeutic Product knowledge
- Responsibilities include site selection and KOL selection.
Clinical Programs Scientist/PM (Shire pharmaceuticals)
05.2016 - 04.2017
- Project Manager in Pediatric Clinical trial in Ulcerative colitis
- Responsible for leading the trial team to develop the operational plan and end to end trial coordination including vendor management and vendor selection
- Responsible for providing strategic and operational leadership to CRO Clinical Project Manager
- Responsible for ensuring quality, timely oversight, and efficient execution of trials, required regulations, and business needs
- Responsibilities include, site evaluation and boosting activities in close collaboration with Medical Monitor.
Sr./Lead Clinical Research Associate (Biosense Webster J&J)
05.2011 - 11.2015
- Accountable for providing strategic and operational leadership, including training/ mentoring to Country Clinical Monitors in their assigned area
- Responsibilities include site evaluation, initiation, monitoring and closure according to applicable SOPs and international/ local guidelines for First in Human and post-marketing trials in Atrial Fibrillation
- Prepared and Attended audits with only 2 minor findings and completed CAPA report
- Performed site and outsourced CRA management and co-monitoring
- Cooperated in the pilot for risk-based monitoring
- Performing case attendance requiring High Clinical and Therapeutic Product knowledge.
Sr. Clinical Research Associate (MSD)
01.2010 - 05.2011
- Responsibilities include site evaluation, initiation, monitoring and closure according to applicable SOPs and international/ local guidelines for Phase Ib, Phase III and Phase IV studies in Hematology, Cardiology and Anesthesiology
- Prepared and Attended audits without findings
- Performed site management
- Responsibilities included Local Project Management single site Phase 1B in Hematology.
Clinical Research Associate
Quintiles
12.2006 - 01.2010
- Responsibilities include site evaluation, initiation, monitoring and closure according to applicable SOPs and international/ local guidelines for Phase II and Phase III studies in Oncology, Hematology, Osteoporosis
- Prepared and Attended audits without findings
- Performed site management.
Nurse ER/ICU
UZ Leuven, UZ Gent, UZ Brussel
09.2002 - 12.2006
Education
Postgraduate Emergency and Intensive Care, Vormingscentrum Antwerp -
01.2002
Graduated Nurse, Sint- Elisabethinstituut, Katholieke Hogeschool Leuven -
01.2001
Foreign Internship Denmark, Righospitalet Kopenhagen (Infectious disease HIV) -
Skills
- Project management
- Achieving project deliverables
- Coordinating cross-functional teams
- Facilitating effective communications
- Strong organizational skills
- Alerting management Quality issues
- Milestone driven Goal-oriented approach
- Employee Motivation
- Milestone driven Goal-oriented approach
- Employee Motivation
- Milestone driven Goal-oriented approach
- Employee Motivation
Extracurricular experience
- Lifeguard and swimming coach
- Head Leader of Youth movement
- Life rescuer (Boat rescuer Bloso)
Languages
Dutch
First Language
French
Intermediate (B1)
B1
English
Proficient (C2)
C2
Deutsch
Beginner (A1)
A1
Danish
Beginner (A1)
A1
IT skills
In dept knowledge of MS word, Excel, Powerpoint, Outlook, Different clinical Trial management systems and databases, Teams, Zoom
Timeline
Senior Global Trial Leader Medical Affairs Delivery Unit
J&J Innovative Medicine( Former Janssen Farmaceutica)
07.2020 - Current
Clinical Project Manager start up Ophthalmology (Istar)
FirstWave Clinical Consultancy
10.2018 - 07.2020
Clinical Project Manager Medical Devices (Terumo Europe)
04.2017 - 04.2018
Clinical Programs Scientist/PM (Shire pharmaceuticals)
05.2016 - 04.2017
Sr./Lead Clinical Research Associate (Biosense Webster J&J)
05.2011 - 11.2015
Sr. Clinical Research Associate (MSD)
01.2010 - 05.2011
Clinical Research Associate
Quintiles
12.2006 - 01.2010
Nurse ER/ICU
UZ Leuven, UZ Gent, UZ Brussel
09.2002 - 12.2006
Postgraduate Emergency and Intensive Care, Vormingscentrum Antwerp -
Graduated Nurse, Sint- Elisabethinstituut, Katholieke Hogeschool Leuven -
Foreign Internship Denmark, Righospitalet Kopenhagen (Infectious disease HIV) -
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