Dr. Andreas Schäfer

- Provide operational leadership for a cluster of countries in driving the organization towards established goals (business, client & quality) - Lead a team of operations managers within countries in Cluster - Overall accountability for the quality, performance and GCP compliance as well as the financial delivery (profitability, utilization and productivity gains as well as prevention of out of scope/contract work)

Territory Director - Head of Sites, Head of Medical Affairs bei Accelerated Enrollment Solutions (a PPD company)

• General management of the Clinical Operation department for Germany, Austria and Switzerland in a metric environment • Successful financial delivery exceeding company expectations • Implemented business and departmental development strategies including process excellence and quality management initiatives

Head of Client Project Management and Account Leader

- Supervision of in/direct reports within ClinOps in a matrix environment - Performance review, management and development (PMD) - Leader of local training and development program - Selection/ Recruitment of new staff - Resource management Clinical Operations - Conduct on-site Quality Control Visits (Evaluation and CQCs) for Clinical Operations staff - Utilization analysis and reporting - Client management to maintain and acquire additional new business

Responsible for the whole Lifecycle of clinical trials from set-up to end of trial. Supervision of mixed teams of CRAs and CPAs, EC- and regulatory submissions, budged calculations, performance and/or qc visits, organization of monitoring team meetings, trip report review, etc. for phase I – IV as well as NIS, PASS and IST studies, CRA development/training, vendor Management, etc…

ICH-GCP conform conduction of feasibilities, Pre-Study, Site-Initiation, Site-Monitoring and Close-out Visits for phase I – IV clinical studies, Mentor of 8 colleagues, candidate selection process (interview process and CV review), participation and organization of company and training meetings (SOPs or various computer based systems) and “Personal development” discussions with colleagues

ICH-GCP conduction of feasibilities, Pre-Study, Site-Initiation, Site-Monitoring and Close-out Visits for phase II – IV clinical studies

DFG Scholarship: GK 1045 “Modulation of host cell functions to treat viral and bacterial infections”

Diploma in biology at the Department of Microbiology and Gentechnologie of the University of Bielefeld “Characterisation of a soil isolate belonging to the genus Paracoccus and the complete sequencing of its 22kb plasmid including a functional gene analysis.”