Experience

Clinfidence BV

• Biotechnology
• 1 - 100 Employee

• Director Data Management / Senior Data Manager

  • Mar 2017 - Present

  I have more than 20 years experience in clinical data management. I have more than 20 years experience in clinical data management.



PSDM

• Industry Associations

• Bestuurslid PSDM (sectetaris)

  • May 2022 - Present

  Board member of a Dutch Working Group for Pharmaceutical Statistics and Data Management (PSDM) Board member of a Dutch Working Group for Pharmaceutical Statistics and Data Management (PSDM)



Accelovance, Inc.

• Senior Data Manager

  • May 2011 - Mar 2017

  - Setup EDC studies and act as liaison between client and EDC vendor. - Create Data Management documents, including Data Management Plan and Data Validation Plans for paper and eCRF studies - Database design and programming of validation checks in Clintrial. - Data cleaning activities in Clintrial - Coordination of IWRS validation activities - Liaise with IWRS vendor and client to define and streamline processes, including unblinding activities - Provide Data Management training to clients and a Masterclass at yearly Dutch CRA event (see http://nvfg.nl/upload/file/Masterclass%20Data%20Management.pdf) - Project support activities to partner drug development company, including project management, vendor management, and compiling complete CSRs (including appendices). - Provide Data Management support to a healthy food company, including coordination of eCRF setup by vendor and User Acceptance Testing (by project team in Singapore). This is also the first project for this client (with a new vendor) that utilizes electronic diaries and questionnaires to be completed by the subjects on smartphones or tablets. - Role as Quality Manager for a small pharmaceutical company, thereby setting up its Quality System. Show less



Julius Clinical

• Netherlands
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Safety Officer

  • Apr 2011 - May 2011

  - tracking and processing of mortality cases for a large (85000 subjects) vaccination trial in elderly subjects - SAE status reporting to internal and external parties - User Acceptance Testing of a newly developed pharmacovigilance workflow application - tracking and processing of mortality cases for a large (85000 subjects) vaccination trial in elderly subjects - SAE status reporting to internal and external parties - User Acceptance Testing of a newly developed pharmacovigilance workflow application



Clinquest, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Pharmacovigilance Associate (ad interim position)

  • Feb 2011 - Mar 2011

  Writing case narratives for a stenting study. Writing case narratives for a stenting study.



IATEC BV

• Netherlands
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Manager Biometrics / Project Manager

  • Jul 2009 - Dec 2010

  As Manager Biometrics and member of IATEC’s Management Team I was responsible for the budget proposals, planning, conduct, and quality of the activities and deliverables of the Biometrics department, consisting of Data Managers, Clinical Programmers, and Statisticians. I often had a role as Project Manager in a number of projects and I was leading the implementation of IATEC's Data Management and EDC systems.

• Project Manager Data Management

  • 2008 - Jul 2009

  Project Manager for projects that include Biometrics activities (Data Management / Clinical Programming / Statistical Analysis).

• Senior Data Manager

  • Jan 2006 - Jun 2009

  In addition to Data Management activities for a number of studies in different indication area’s (HIV/AIDS, Cardiovascular, Osteoporosis, and Oncology), I was responsible (together with the Director Biometrics) for the planning of Data Management activities within the Biometrics Department. As a coach for the Data Managers I was usually the primary contact in case of Data Management issues. Besides this I supervised the Data Entry staff.I was also responsible for keeping the Data Management manuals and SOPs up to date and provided input on draft study protocols. In addition, I kept track of the Data Management status of all running projects and reported this to the Director Biometrics.I also gained a lot of experience in providing training on Data Management and Drug Safety, for example to research professionals in Bangkok, Thailand. Show less

• Drug Safety Officer

  • May 2002 - Oct 2008

  I was responsible for SAE and SUSAR reporting according ICH/GCP guidelines and EU directive 2001/20/EC. Under supervision of the Medical Affairs Manager I created a number of SAE manuals and Medical Monitor Manuals. In addition, I provided SAE training for IATEC employees.

• Member of business unit team specialized in Metabolic Disorders

  • 2008 - 2008

  I supported Business Development during demos of our systems to potential clients and provided input on business proposals. As a member of the Business Unit Metabolic Diseases I was involved in the determination of the strategy of Business Development and identification of potential clients.

• Data Manager

  • May 2002 - Dec 2005

  I was responsible for the review and validation of clinical data in line with ICH/GCP. Initially, the activities mainly consisted of query processing for a large HIV study in 1200 patients. Later I was also involved in setting up other HIV studies and my activities included: CRF design, setting up Data Management and Data Validation Plans, Database Validation, training of Data Entry personnel and coordination of Data Entry activities and Quality Control between CRF and database. I also performed coding of Adverse Events (MedDRA) and Medications (WHOdrug).In addition I coordinated a number of activities during the implementation of IATEC's Data Management system (eDM) and performed the following activities: writing System Validation Plan, Manuals, SOPs, and a Validation Summary Report, design and execution of test scripts to validate the functionality of the system (OQ). Show less



PSDM

• Board Member Working Group

  • May 2008 - Jul 2010

  As board member of a Dutch Working Group for Pharmaceutical Statistics and Data Management (PSDM) I have co-organized and presented at workshops on SAE data reconciliation and on system validation issues. As board member of a Dutch Working Group for Pharmaceutical Statistics and Data Management (PSDM) I have co-organized and presented at workshops on SAE data reconciliation and on system validation issues.



Nederlands Kanker Instituut

• PhD Student

  • Jul 1997 - May 2001

  Study on anti-tumor effects of alkyl-lysophospholipds. PhD since 2003. Study on anti-tumor effects of alkyl-lysophospholipds. PhD since 2003.