Sr. Consultant Clinical Operations

10/2014 – 6/2016

In this role I was in charge of performing 30 accompanied visits per year in Europe, in order to identify
site management issues, analyze the data collected to see a trend, liaising with Operational Excellence, TA-Heads,
as well as Line-Management in order to implement global mitigation strategies

Pharmaforschung

9/2012 – 8/2014

My role was the management of up to 3 phase IIa - III clinical trials as per ICH-GCP guidelines, EMEA-, as well as
FDA- regulations, local requirements and study requirements, including leveraging the newly implemented
strategic (CRO-) partnership, liaising with internal as well as external stakeholders

Achievements:
• Ensured CRO taking over ownership of conducting a trial successfully by
◦ establishing the relationship with strategic partner resulting in a better understanding of study requirements
◦ ensuring compliance with operational manual for outsourced trials by liaising with internal stakeholders as well as with the external service provider (ESP) by developing and deploying study plans resulting in a mutual understanding of the partnership strategy
• Provided accurate budget figures to Senior Management by
◦ forecasting costs, setting -up accruals and managing vendors resulting in budget oversight
◦ developing and providing tools and intense training to the strategic partner in charge of vendor- and finance management enabling the strategic partner to deliver as per service agreement
• Identified and resolved systemic, as well as vendor performance issues by
◦ providing mitigation proposals resulting in a reduction of quality issues
• Ensured efficient study conduct by
◦ managing internal, as well as CRO study teams effectively, meeting deadlines without delay
• Reduced study risks by
◦ providing mitigation strategies and monitoring of vendor follow-up-activities

Medizinforschung, Pharmaforschung

6/2010 – 5/2011

Coordination of site management activities
Line-Management of CRAs
Study -Start-up activities

Pharmaforschung