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Summary

7-year-experience in Clinical trials - self-driven and open to new challenges - eager to evolve in a global environment

Experiences

Current Experience

  • Associate Project Manager Study Start-up


    Since January 2016
    •serve as client primary contact for ssu activities : meet/exceed client satisfaction expectations as well as develop and maintain relationships with assigned clients •contribute to the effective Teamwork among project team members within covance departments and offices and contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects •cross-unit coordination both internal and external, inclusive of sub-contractors, for projects utilizing one or more covance services or sites •assist in the management and tracking of project resource needs and contribute to contingency Planning for key resources •assist in the successful design, implementation, tracking and revision of project plans for assigned projects •assist in the Leadership of the core project team to facilitate their ability to lead extended/complete project team including the maintenance of timelines in MS Project, creation of PowerPoint Presentations and storyboards and maintenance and escalation of items •ensure that all staff allocated to assigned projects adheres to professional standards and sops •interpret Finance guidelines for functional area •follow defined project issue escalation process •identify and assess risks and maintain associated Documentation, track project progress against financial milestones using applicable financial systems •Serve as client primary contact for SSU activities : meet/exceed client satisfaction expectations as well as develop and maintain relationships with assigned clients •Contribute to the effective teamwork among project team members within Covance departments and offices and contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects •Cross-unit coordination both internal and external, inclusive of sub-contractors, for projects utilizing one or more Covance Services or sites •Assist in the management and tracking of project resource needs and contribute to contingency planning for key resources •Assist in the successful design, implementation, tracking and revision of project plans for assigned projects •Assist in the leadership of the core project team to facilitate their ability to lead extended/complete project team including the maintenance of timelines in MS Project, creation of PowerPoint presentations and storyboards and maintenance and escalation of items •Ensure that all staff allocated to assigned projects adheres to professional standards and SOPs •Interpret finance guidelines for functional area •Follow defined project issue escalation process •Identify and assess risks and maintain associated documentation, track project progress against financial milestones using applicable financial systems

Past Experience

  • Start Up Specialist

    March 2014 --- December 2015
    •delivery of the global site services (gss) component of assigned studies in belgium and the netherlands, including accountability for delivery to time, cost and quality for assigned activities •act as primary contact with investigative sites during site start-up activities •site contracts negotiations •responsible for working with investigative sites to collect the required Investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, eu Clinical Trial directive, ich-gcp, FDA regulations and/or the study sponsor •responsible for maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the Clinical Trial •work with staff in operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global Clinical trials

  • Assoc. RSU Specialist - Translation Coordinator

    February 2011 --- March 2014
    *coordination of translations; negotiations of prices and deadlines with Translation agencies; adaptation to belgium requirements, Translation and review of patient documents and labels * submissions to ec and ra in belgium

  • Sales Associate

    February 2010 --- August 2010
    clients prospect

  • Senior Trainer

    February 2010 --- August 2010
    English and French Trainer at various companies

Personality

Self Assessment :
AdaptabilityAssertivenessAttention to detailCoordinationCritical thinkingEfficiencyEgoismInterest in knowledgeOptimismProactivityProblem solvingSelf-confidenceStriving

Knowledge

LinkedIn Assessment :
Pharmaceutical IndustryGCPCROICH-GCPClinical DevelopmentCTMSRegulatory affairsSOPClinical researchInformproactiveEye for DetailsCommunication SkillsTranslationProject CoordinationCustomer ServiceLeadershipLinguisticsProject Management

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF)Act as the main line of communication between the sponsor and the investigatorAdvise on strategyCollaborate with project teamCommunicate with sponsorContract approvalCoordinate ethics committeeCoordinationCreate clinical project documents according to the protocolDevelop study metricsDirect co-workers to achieve resultEthics committee applicationEthics committee submissionsInitiate clinical trials Lead teamsManage Clinical Trial Management System (CTMS) project managementReferral lettersRegulatory submissionsSolve problemsUnderstand protocolsWork collaboratively with the other members of the clinical research team Work cross-functionally

Education

  • Master’s Degree in Management from Ichec Brussels Management School in 2017
  • Master's degree in Translation International Relations from Institut Supérieur de Traducteurs et Interpretes, Uccle in 2009

Training and Certification

  • ICH-GCP in 2015 Certification

Languages

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

Work Preferences

  • Notice Period:
    7 weeks
  • Positions I am interested in:
    associate Clinical Project Manager Clinical Project Leader Project Manager Clinical Study Manager Clinical Trial Manager
  • Work From Home:
    Yes, 2 to 4 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Bruxelles

Others

Driving License
  • Yes

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