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Summary

In the past 18 years I have gained (inter)national experience within Pharmaceuticals and Medical Devices, mainly in the therapeutic areas gynecology and andrology. I have been involved in the design, conduct and reporting of clinical trials, in the upgrade of the company’s Quality System towards certification, and in CE labelling. I have good knowledge of regulations and guidelines regarding conduct of clinical studies and CE labeling of medical devices. I am result driven, efficient and structured, capable of creating a good atmosphere in a team by expressing enthusiasm and strong drive. I have a great sense of responsibility and eye for quality.

Experiences

Past Experience

  • Clinical Director Scherpenzeel, Nederland
    January 2007 --- September 2014

     

    Responsibilities:

    • Developing and executing Clinical Development Plans in line with the strategy of the company;
    • Developing and implementing Post Marketing and Product Surveillance procedures;
    • Risk assessment;
    • Writing of Investigator's Brochure and Product Monograph;
    • Involvement in the upgrade of the Quality System towards ISO 13485;
    • Involvement in the design and development of the device;
    • Developing and implementing Standard Operating Procedures for the conduct of Good Clinical Practice (GCP) studies;
    • Writing clinical trial protocols and reports, coordinating study activities, monitoring progress, and realizing publications for Delphi Bioscience-initiated studies;
    • Supporting clinical trial related activities (see above) for investigator-initiated studies;
    • Keeping up-to-date with, and informing the company of, medical and scientific developments of the product and the strategic fields of the company;
    • Supporting marketing/sales activities, including preparation of training manuals;
    • Keeping up-to-date with (inter)national guidelines and legislation such as the Medical Device Directives (focus on vigilance and clinical evaluation), the ‘Wet Bevolkingsonderzoek’ and self-tests;
    • To effectuate a network of international scientific experts.

  • Medical Advisor Oss, Nederland
    January 2006 --- December 2006

    Responsibilities MA contraception:

    • Keeping track of product development;
    • Executing observational research;
    • Providing medical support to marketing and sales activities;
    • Writing/supporting writing of medical publications;
    • Giving presentations;
    • Providing a medical training program (sales force);
    • Release of communication materials.

  • Specialist manager Oss, Nederland
    January 2005 --- December 2005

    Responsibilities SP gyneacology:

    • Achieving yearly sales target (contraception and hormone therapy product);
    • Visiting general practitioners and gynecologists according to the target;
    • Building and maintaining relationships;
    • Initiating, or participating in, activities such as DGMs

  • Medical Advisor Oss
    June 2003 --- December 2004

  • Medical Advisor Oss, Nederland
    January 2001 --- May 2003

    Responsibilities International MA Androgens:

    • Team leader of two Clinical Trial Teams (international studies with an anabolic-androgen conducted in Australia, Asia, North and South-America and Europe);
    • International Clinical Development Team Leader;
    • Member of the International Project Team;
    • Preparation of an International Publication Plan;
    • Providing medical support

  • Clinical Research Coordinator Oss, Nederland
    November 1998 --- December 2000

    Responsibilities:

    • Member of the two Clinical Trial Teams (see above);
    • Involved in design of protocol and CRF;
    • Determining personnel costs of trial budget;
    • Organizing investigator and CRA meetings;
    • Monitoring of progress and quality

  • Clinical Research Coordinator São Paulo, Brazilië
    June 1996 --- October 1998

    Responsibilities:

    • Two CRA line reports;
    • Rewriting/adapting protocols from NV Organon;
    • Planning of trials in preparation;
    • Coordinating the activities;
    • Monitoring of the progress.

  • Clinical Research Associate (CRA) Oss
    June 1995 --- May 1996

Knowledge

Self Assessment :
Medical devices Scientific writingCAPAClinical DevelopmentClinical researchClinical Study DesignClinical trial managementClinical study reportsDesigning case report formsFDAGood Clinical Practice (GCP)GynecologyInformed Consent ProcessInterpret clinical trial resultsMedical writingPharmaceutical IndustryPhases of clinical development (phase I to IV)Project ManagementWomens HealthInformed Consent DocumentsSerious Adverse Event (SAE)SOPWriting Study Procedures and SOPs

Skills and Expertise

Self Assessment :
Create SOPs Build and manage the Trial Master File (TMF) Design case record forms Develop clinical trial protocols Interpret data Monitor a clinical study Report data Write papersAdverse event reportingApprove monitoring reportsCalculate trial timelinesWrite protocols Control dataWrite medical reportsTrain on site staffSupervise clinical monitorsSite managementSet up a clinical studyScheduling trial visitsSchedule sponsor monitoring visitsReview study protocolsClinical data collectionCollaborate with project teamCommunicate with investigatorComplete study proceduresConfirm protocol complianceDesign clinical trialDesign information leafletDesign post-marketing surveillance studyDevelop clinical strategyMaintain Quality Management System (QMS)

Education

  • master in Medical Biology from Vrije Universiteit in 1993

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Professional Proficiency
Portuguese
Elementary Proficiency
German
Elementary Proficiency

Work Preferences

  • Positions I am interested in:
    Clinical Project Manager (CPM)
  • Work From Home:
    Yes, 1 to 3 days per week
  • Work Regime:
    BrightOwl freelancer :    20 Hours per week
  • International:
    No

Area / Region

Gorinchem, Nederland

Others

Driving License
  • Yes