Experience

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  Quintiles

  Dec 2007 - Jun 2016

  Associate director, site management , alliance trainer and strategic consultant

  Alliance Education- providing trainings for site , monitors and any other relevant staff according to needs ( GCP , source data verification , ICF process , clinical trials regulations etc.)•Mentoring and coaching monitors and Prime Site Managers at the regional level within Eastern Europe •Relationship Building - Managing expectations• Feasibility - Turnaround timelines• Site List Generation / Turnaround timelines• Master CDA use• CDA negotiation process• Take care that site accepts 70-90% of offered studies• Contracting support• Regulatory Document Collection support• Study Selection Support• Study Initiation Support• Enrollment Support• A point-person for escalation of various study issues (payments, staffing, data entry, queries, etc.)• Study Close-out Support• Capabilities Analysis- monthly report• Identifying new investigators• Gap & Pipeline Analysis• Metric Review• Effectively communicate and describe service to internal and external customers.• Drive quality by process improvement initiatives related to corporate or departmental strategic plans.• Serve as the regional support for established Prime Sites in EE .• Biosimilar campaign working group member and coordinator of the project implementation internally and externally• Member of the initial working group that created the content of the Site Training & e-learning platform for Investigators •consultant and supporter for Polish Prime Site in the process of developing and activating dedicated Phase I unit within their structure•involvement into the early stages capability landscape for Central & Eastern Europe (CEE )• consultancy support in the new initiative implemented by the Prime Site Target – Innovations - „ Research and development program” with main aims at analyzing of optimal cooperation model on planning and conducting clinical trials. •creating and implementing strategic plan of development for the Prime Site Show less

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  Merck group

  Nov 2016 - now

  • Senior Clinical Site Lead

    Oct 2019 - now

  • Site Relationship & Operational Lead CEE

    Nov 2016 - Oct 2019