BrightOwl Loader Loading

Summary

Summary:

I have more than 20 years’ experience in a large international pharmaceutical concern. I am efficient, accurate and I always look with a critical eye and show initiative. With this skill set I am able to perform a large amount of work in a relative short time period and maintain the needed high quality.

I am a well-motivated team-player, also capable to work independently. Besides being assertive and capable of giving my opinion, I show strong empathy and social skills.

 Work experience:

 November 2015 – February 2016: Local Clinical Trial Assistant at Janssen-Cilag B.V., Tilburg/Beerse

  • Support the Local Trial Manager and Site Manager(s) to ensure optimal management of all documents with logistical and administrative tasks related to execution of clinical trials.
  • Maintain site level protocol information in Trial Management Systems (e.g. sCTMS, VTMF, Masterlist)
  • Ensure, in liaison with the LTM and/or SM, current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.

 2013 – 2015: Management Assistant external data at Merck Sharp & Dohme (MSD), Oss

  • Important deadlines have been accomplished due to my pro-active manner of communication with data suppliers and study teams.
  • By being open minded towards other attitudes, cultures and traditions, I was able to have an open dialog and receiving my information on time.
  • I critically review text, user guides and SOP’s, to get the best feel for the job at hand, and suggest options to get them improved. Supporting the efforts for the most efficient method of working.
  • Check provided data and if necessary have errors corrected. Quality in the data is achieved by flexible communication with suppliers and study teams.
  • Archive documents and reports in several data share points, such as Documentum, Teamspace and Midas.

 2003 – 2013 Clinical Management Assistant at Merck Sharp & Dohme (MSD),
                                                                                    Schering-Plough and NV Organon, Oss

  • As one of my colleagues became ill and an interim project manager was needed ad hoc. I was able to make the deadline and obtain database lock for that study. By taking initiative, being inventive and especially daring to ask.
  • When in the department pressure on other teams were rising and backlogs where building. I spontaneously offered support to needy teams to help reduce/remove backlogs, so deadlines could be met.
  • Validate data in several systems like Oracle Clinical, Macro, Clintrial and Inform.
  • Generate and send queries for worldwide studies.

1976 – 2003:

Assistant Clinical Supplies Management at NV Organon, Oss

  • Preparing packing instructions for medication to be used in worldwide clinical studies, taking into account government requirements for each country.
  • Worldwide communication with employees concerning the content of these orders.
  • Administratively preparing and giving advice on shipments for study medication with accompanying documentation (specific for each clinical study and country and within timelines).

Data Entry at NV Organon, Oss

  • Input CRF data from subjects participating in a clinical study

Assistant Medical Registration at 2 hospitals, Oss and Boxtel

  • Coding hospitalization data, such as reason, possible operation and causality such as an accident.
  • Communication with patients by phone to confirm the date and time of hospitalization.
  • Internal communication with the physicians and medical secretaries.
  • Archiving of patient files.

 Most important Education and  Courses:

HAVO, College van het Heilig Kruis te Uden, diploma

March 2016: PowerPoint Training, certificate

March 2016: Excel Basic and Advanced Training, certificate

September 2015: SAP Basic Training, certificate

2014: Six Sigma Yellow Belt Training

2008: Verbal and Written proficiency in English

2007: Functioning in teams

2007: ICH-GCP

2005: Medical Terminology

Experiences

Past Experience

  • Clinical Trial Assistant (CTA) Tilburg, Netherlands
    November 2015 --- February 2016

    Local Clinical Trial Assistant at Janssen-Cilag B.V., Tilburg/Beerse

    • Support the Local Trial Manager and Site Manager(s) to ensure optimal management of all documents with logistical and administrative tasks related to execution of clinical trials.
    • Maintain site level protocol information in Trial Management Systems (e.g. sCTMS, VTMF, Masterlist)
    • Ensure, in liaison with the LTM and/or SM, current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.

     

  • Management Assistant External Data Oss, Netherlands
    January 2013 --- February 2015

    Management Assistant external data at Merck Sharp & Dohme (MSD), Oss

    • Important deadlines have been accomplished due to my pro-active manner of communication with data suppliers and study teams.
    • By being open minded towards other attitudes, cultures and traditions, I was able to have an open dialog and receiving my information on time.
    • I critically review text, user guides and SOP’s, to get the best feel for the job at hand, and suggest options to get them improved. Supporting the efforts for the most efficient method of working.
    • Check provided data and if necessary have errors corrected. Quality in the data is achieved by flexible communication with suppliers and study teams.
    • Archive documents and reports in several data share points, such as Documentum, Teamspace and Midas.

     

  • Clinical Management Assistant Oss, Netherlands
    September 2003 --- January 2013

    Clinical Management Assistant at Merck Sharp & Dohme (MSD), Schering-Plough and NV Organon, Oss

    • As one of my colleagues became ill and an interim project manager was needed ad hoc. I was able to make the deadline and obtain database lock for that study. By taking initiative, being inventive and especially daring to ask.
    • When in the department pressure on other teams were rising and backlogs where building. I spontaneously offered support to needy teams to help reduce/remove backlogs, so deadlines could be met.
    • Validate data in several systems like Oracle Clinical, Macro, Clintrial and Inform.
    • Generate and send queries for worldwide studies.

     

  • Assistant Clinical Supplies Management, Data Entry and Assistent Medical Registration Oss, Netherlands
    August 1976 --- September 2003

    Assistant Clinical Supplies Management at NV Organon, Oss

    • Preparing packing instructions for medication to be used in worldwide clinical studies, taking into account government requirements for each country.
    • Worldwide communication with employees concerning the content of these orders.
    • Administratively preparing and giving advice on shipments for study medication with accompanying documentation (specific for each clinical study and country and within timelines).

    Data Entry at NV Organon, Oss

    • Input CRF data from subjects participating in a clinical study

    Assistant Medical Registration at 2 hospitals, Oss and Boxtel

    • Coding hospitalization data, such as reason, possible operation and causality such as an accident.
    • Communication with patients by phone to confirm the date and time of hospitalization.
    • Internal communication with the physicians and medical secretaries.
    • Archiving of patient files.

Personality

Self Assessment :
EfficiencyCritical thinkingAssertivenessCommunicativeFlexibilityInterest in knowledgeProactivityResponsibilitySociabilityTrust

Education

  • HAVO in not available from College van het Heilig Kruis in 1976

Training and Certification

  • Functioning in teams in 2016 Training
  • ICH-GCP in 2015 Training
  • Six Sigma Yellow Belt in 2014 Training
  • Excel Advanced in 2016 Certification
  • Excel Basic in 2016 Certification
  • PowePoint in 2016 Certification
  • SAP Basic in 2015 Certification
  • Medical Terminlogy in 2005 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
Dutch
Native

Area / Region

Oss, Netherlands

Others

Driving License
  • Yes