Monika Huber
Senior Director Project Management- Ips @Thermo Fisher Scientific
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WORK HISTORY
Senior Director Project Management- Ips @Thermo Fisher Scientific
EDUCATION
Vocational Training School for Medical Assistants
Certified Medical Assistant
ABOUT MONIKA HUBER
Operations SME for the OF team supporting financial analysis, process enhancements, training development around project financial management. Management of global clinical trials, leading cross functional project teams including clinical operations, regulatory, biostats, data management, medical services, PVG, and third-party vendors, to ensure quality, on-time and within budget deliverables for Phase II-IV clinical trials in various indications. Participation in bid defense meetings, company presentations. Strategic consultancy for clients in the planning and implementation of major project changes, e.g project rescue, alignment to revised regulations/SoC, business competition. Review and analysis of company internal standards, processes and guidelines. Compliance review for adherence to business and company regulations. Implementation of risk management on project and corporate level, globalization of processes and systems within an affiliate setting. Training of Project Managers and operational staff (internal and public courses), mentoring of project managers. Line management of international teams. 20+ years of experience in clinical research. Used to work accross 24 time zones, enjoying the variety of cultures and the fact that you can build an amazing team spirit and a great working together by email and phone only. Enjoying the opportunity to do something which makes sense.
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