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Summary

Consultant Clinical research for Medical Devices and Pharmaceuticals. manage and lead the day-to-day Operations of assigned studies to ensure completion per established project team goals and objectives in Compliance with applicable gcp/ICH guidelines and other regulatory requirements manage and lead cross-functional study teams, including vendors provide accurate and up-to-date study information within relevant tracking systems and provide regular updates of study progression and resolve issues that arise during study conduct; manage escalation of study-related issues lead development of study plans and system set-up; participate in preparation and ensure Operational Excellence of science)" >Protocol, crf, csr and other key study team deliverables implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team lead feasibility assessment and selection of countries and sites for study conduct oversee the clinical aspects of timely Data cleaning, Data Analysis and the availability of top line results; participate in data reviews and review of Statistical analysis plans ensure set-up and implementation of effective Investigator and site monitor Training; coordinate operational and therapeutic area Training for internal and external study team members. provide oversight and direction to study team members for study deliverables. international experience: europe, us. 2007 – feb 2013 line manager for several companies as a contractor: Planning and organizing work for cras managing finances and resources annual review, Training and development managing poor performance Recruiting new staff redundancy/end of employment troubleshooter

Experiences

Current Experience

  • Consultant Clinical Manager Medical Device


    Since January 1996
    as a contract Coordinator in Project Management for several Medical Device and Pharmaceutical/biotech companies Sales, Marketing and Clinical research general Planning recruitment/ selection of investigators/subinvestigators/site-change coordinate irb submission/Health authorities preparing documents for international submission review regulatory documents initiation visits monitoring studies to meet the gcp/ICH guidelines FDA regulations nordic guidelines ISO 14155 study close-out visit establishing and managing a study team ensuring effective Communication of study related issues within the study team as a contract CRA/Coordinator for several medical companies Clinical research support Project Management product presentation booth representation Market research Training course registration help product in different countries Business Development market studies ad hoc management assistance development new accounts distributors recruitment and Sales/educational meetings Training of distributors and investigators for Medical Device products providing disease and product-specific information to physicians and other Health professionals international experience: denmark the netherlands austria england sweden norway germany switzerland belgium italy spain france As a Contract Coordinator in Project Management for several Medical Device and Pharmaceutical/BioTech Companies Sales, marketing and clinical research General Planning Recruitment/ selection of Investigators/subinvestigators/site-change Coordinate IRB submission/Health Authorities Preparing documents for international submission Review regulatory documents Initiation visits Monitoring studies to meet the GCP/ICH guidelines FDA Regulations Nordic guidelines ISO 14155 Study Close-out Visit Establishing and managing a study team Ensuring effective communication of study related issues within the study team As a Contract CRA/Coordinator for several Medical Companies Clinical Research support Project Management Product Presentation Booth representation Market Research training course Registration help product in different countries Business Development Market studies Ad hoc management assistance Development new accounts Distributors recruitment and sales/educational meetings Training of Distributors and Investigators for Medical Device products Providing disease and product-specific information to physicians and other health professionals International experience: Denmark The Netherlands Austria England Sweden Norway Germany Switzerland Belgium Italy Spain France

Past Experience

  • External Confidential Advisor/ Vertrouwenspersoon

    January 2007 --- March 2014

  • Consultant Clinical Research

    May 1994 --- March 2014
    as a contract Coordinator in Project Management for several Medical Device and Pharmaceutical/biotech companies Sales, Marketing and Clinical research general Planning recruitment/ selection of investigators/subinvestigators/site-change coordinate irb submission/Health authorities preparing documents for international submission review regulatory documents initiation visits monitoring studies to meet the gcp/ICH guidelines ind/nda/ide FDA regulations nordic guidelines ISO 14155 study close-out visit establishing and managing a study team ensuring effective Communication of study related issues within the study team provide status reports set up appropriate Planning of the study responsible for the management of trials to timelines and Budgets coordinate and attend Investigator meetings reviewing of and writing administrative section of science)" rel="nofollow">Protocol/reports (clinical) organization and coordination with european central Laboratory international experience: denmark the netherlands austria england sweden norway germany switzerland romania belgium italy spain france

  • Clinical Research Associate (CRA)

    January 1993 --- January 1994

  • Clinical Research Associate (CRA)

    January 1991 --- January 1993

  • Clinical Research Associate/Data monitor

    January 1989 --- January 1991

Knowledge

LinkedIn Assessment :
Pharmaceutical IndustryClinical trialsClinical researchCTMSMedical DevicesClinical monitoringClinical DevelopmentGCPICH-GCPCROInfectious diseasesPharmacovigilanceEDCFDAProtocol

Education

  • in from - in 1989
  • Bachelor in Medicine from University of Amsterdam in 1984

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
Dutch
Native

Area / Region

Amsterdam, Nederland

Others

Driving License
  • Yes

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