Successfully completed various controlling projects
Over 10 years’ of professional experience as a Clinical Research Professional
Experience with the Phases I – IV in different therapeutic areas (Oncology, Dermatology, Cardiology, etc.)
Successfully placed as a Senior Clinical Operations Manager via K-Recruiting
Very experienced in solving problems and finding solutions tailored to individual requirement
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Our content and services may vary by location.
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Master of Science in Pedagogy
- Language Skills
- Czech (native), English (business fluent)
- Relevant Expertise
- Clinical Trials, Study Start Up, Contracting and Budgeting, Senior Clinical Research Associate, Good Clinical Practice, Risk Based Monitoring, Site Prepatation, Study Documentation, Submission to Ethic Committees & Authorities, Pharma
Key-Facts
Extract from previous activities
Biopharmaceutical Company, United States
Senior Clinical Trial Manager
Responsible for the management and oversight of clinical trials from start up, site and country identification, feasibility process oversight, conduct and reporting including timelines, quality and budget
Leading and coordinating the management, planning and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines on the study level
Development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets
Respiratory, phase II – 72 sites, 200 subjects (1700 subjects, 480 sites globally)
Pharmaceutical Company, Germany (via K-Recruiting)
Senior Project Manager Country Operation
Responsible for the management and oversight of clinical trials, from start up, site and country identification, feasibility process oversight through CSR including, management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines
Development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budget, monitoring oversight of site-level activities related to ongoing and planned trials, management of third-party vendors for clinical services, management of project timelines and deliverables
Rare diseases, phase II, III – Wilson disease, Myasthenia Gravis, PHN, Amyloidosis, Dermatomyositis, Geographic atrophy
Pharmaceutical Company, Switzerland
Senior Clinical Project Manager
Responsible for the management and oversight of clinical trials, management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines
Development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets, monitoring oversight of site-level activities related to ongoing and planned trials
Infection disease / Covid- 19 study – 12 sites, 20 subjects
Gastroenterology – phase IIb – 9 sites, 45 subjects