Experience

Venn Life Sciences - part of hVIVO plc

• United Kingdom
• Research
• 1 - 100 Employee

• Clinical Project Lead

  • Jan 2022 - Present

• Senior Clinical Project Manager

  • Jan 2010 - Dec 2021

  Activities (next to those already mentioned under Clinical Project Manager):• Prepare budget proposals for new clinical trials.• Provide overall trial strategy and regulatory advice on the submission process to sponsors.• Coach junior Clinical Project Managers.• Set up and improve the Trial Management System.• Additionally:­- From March until October 2018 assigned as Project Manager, Development Operations, Galapagos NV, Mechelen, Belgium.­- From 2014 until 2016 assigned as Clinical Research Manager, Infectious Diseases & Virology, Janssen Pharmaceutica NV, Beerse, Belgium. Show less

• Clinical Project Manager

  • Jun 2005 - Dec 2009

  Activities:• Coordinate the full process of initiation, execution and completion of a clinical trial within the agreed timelines.• Lead the clinical study team.• Select clinical site and CROs, including vendor management(e.g. bioanalysis, PK/PD).• Produce clinical trial outlines or review them on feasibility of the trial.• Write clinical trial protocols and other trial related documents.• Oversee all site related activities including submission to EC.• Prepare the Clinical Trial Application including submission to CA.• Review the study related documents e.g. Case Report Form, monitoring plan, monitoring reports, data management/validation plan, statistical analysis plan and pharmacovigilance documents.• Oversee drug supply labeling, packaging, shipment (import) and storage.• Prepare and archive the Trial Master File.• Additionally:­- From January until October 2008 assigned as Clinical Pharmacokinetic Program Manager, Clinical Pharmacology, Janssen Pharmaceutica NV, Beerse, Belgium Show less

• Medical Writer

  • Mar 2002 - May 2005

  Activities:• Write early phase study outlines and clinical trial protocols.• Write pharmacokinetic reports.



Erasmus MC

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

• Data Manager at Trial Office Medical Oncology

  • Apr 1997 - Feb 2002

  Activities: • Plan the enrollment of patients in Phase I oncology trials. • Communicate with pharmaceutical companies. • Complete the Case Report Forms • Organize initiation visits and monitoring visits Activities: • Plan the enrollment of patients in Phase I oncology trials. • Communicate with pharmaceutical companies. • Complete the Case Report Forms • Organize initiation visits and monitoring visits



Bicom Medical BV

• Tiel

• Clinical Trial Assistant

  • Mar 1996 - Mar 1997

  Activities: Interpretation, coding and data entry of patient medical files at general practisioners to investigate the prevention of cardiovascular diseases. Activities: Interpretation, coding and data entry of patient medical files at general practisioners to investigate the prevention of cardiovascular diseases.