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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:

  • 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 science)" rel="nofollow">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

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