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Summary

I started my career in Clinical Research 16 years ago and meanwhile built up a solid knowledge of the industry.
My wish is to become part of a dynamic, innovative company and to apply my project – extensive people management experience to lead a Clinical Operations Team and to contribute to initiatives that realize the mission and business objectives of Clinical Operations.

Experiences

Current Experience

  • Senior Clinical Operations Manager
    Since January 2014

Past Experience

  • Consultant (Local Trial Manager)
    September 2013 --- January 2014
    Responsible for the local management of assigned studies. Leading and coordinating the local trial teams. Contribution to process improvement, training and mentoring of Project Assistants and Clinical Research Associates.

  • Senior Clinical Manager
    October 2004 --- March 2013
    Responsible for the line management, recruitment and selection, training, coaching and performance management of designated Clinical Management staff. Developed and provided training on procedural documents and other processes related to Clinical Management. Provided mentoring, work direction and coaching through activities such as co-monitoring visits, file reviews and visit report reviews. Conducted regular performance appraisals with direct reports and facilitated their professional development. Used metrics and key performance indicators to manage individual and team performance.

  • Project Leader Gastro-Enterology
    January 2003 --- January 2004
    Worked in close collaboration with the Medical Director and the Therapeutic Area Leader. Responsible for budget planning, feasibility checks, organising local investigator’s meetings, coaching, co-monitoring, preparation of the study related documents and communication with headquarters. Assisted the Clinical Data Manager in writing abstracts. Member of the Cross Functional Team (Sales/Marketing).

  • Clinical Research Associate (CRA)
    January 1999 --- January 2003

  • Clinical Research Associate (CRA)
    January 1998 --- January 1999

  • Sales Representative
    January 1993 --- January 1998

  • Graduated Nurse
    January 1987 --- January 1993

Knowledge

LinkedIn Assessment :
Clinical trialsCTMSClinical operationsICH-GCPCROClinical researchClinical DevelopmentPharmaceutical IndustryLine ManagementTherapeutic AreasClinical monitoringEDConcologyPharmacovigilanceTraining

Education

  • Bachelor's degree in from Katholieke Hogeschool Leuven in 0

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
French
Full Proficiency

Area / Region

België

Others

Driving License
  • Yes