Michal Vala

Experience

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  MSD

  Oct 2010 - Oct 2012

  Site monitoring responsibility for clinical studies according to Standard OperatingProcedures, ICH Guidelines and GCPSite management responsibility for clinical studies according to Standard OperatingProcedures, ICH Guidelines and GCP Provide clerical support for clinical projects according to Standard OperatingProcedures (SOPs)Maintain administrative systems (tracking and other) for clinical projects according to SOPsAssume a coordinating role for the project team concerning administrative matters

  • Clinical Research Associate

    Sept 2011 - Oct 2012

  • Clinical Trial Coordinator

    Oct 2010 - Aug 2011
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  Covance

  Oct 2012 - Nov 2019

  Responsible for the supervision of assigned direct, detailed performance review and management of assigned direct reportsMeasure performance indicators for assigned staff, appropriate management and resolution of performance issuesConduct, report and follow-up on Quality Control VisitsEscalate potential individual training needs and assist in the conduct of training anddevelopment efforts, regionallyEffectively communicate management strategies, policies and procedures in conjunction withleadership teamsMaintain good working relationships with internal and external clients to ensure opportunityfor acquiring additional new business Show less

  • Associate Clinical Operations Manager

    Oct 2016 - Nov 2019

  • Senior Clinical Research Associate

    Jan 2016 - Sept 2016

  • Clinical Research Associate II

    Oct 2012 - Dec 2015
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  MSD Czech Republic

  Nov 2019 - now

  Clinical Research Manager

  Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out. Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration Responsible for creating and executing a local risk management plan for assigned studiesResponsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies Show less