Twenty Years Expertise in a Nutshell
Franziska draws from a broad range of expertise and functional knowledge acquired over two decades in pharmaceutical industry and at academia.
Franziska worked in R&D Clinical Operations for both, sponsor and investigator organisations including 16 years in a leadership position of a dedicated phase 1 unit.
Franziska holds a PhD degree from the University of Basel, Switzerland in analytical pharmaceutical chemistry.
Franziska is also member of RQA (MRQA) and certified fellow in clinical research (ACF) with ARCS (Australia)
Management, conduct and supervision of over 130 clinical studies predominantly phase 1 and 2 for sponsors in the US, Europe, Japan, Korea and China
Comprehensive range of therapeutic areas including oncology
Management of multi-centre studies and sites
Medical writing and study design
Quality and Audits
Management and conduct of sponsor and internal audits
Development and implementation of quality management systems covering all aspects of clinical site operations
SOP development and SOP management systems
GCP, GCLP, cGMP (IMP related), computer system compliance (21CFR11), ISO9001
Experience with regulatory requirements of various authorities including TGA, MHRA, EMA, FDA, PMDA, MHLW
Requirements for studies in ethnic subpopulations e.g. bridging studies in north east Asian volunteers and patients
Management of regulatory inspections and pre-inspection readiness
Clinical Site Operations
Phase 1 clinical trial facility and operation set-up, development, management and decommissioning
Provision of support to academic and government organizations in Asia, South America and Australia in developing, expanding and improving their clinical research operations
Leadership and Management
Leadership of cross-functional high performance teams and creation of engaged, supportive and inclusive working environments
Establishment of strategic and business relationship globally
Teaching and Training
Convenor and tutor in the post-graduate course of Clinical Development of Medicines at the University of NSW
Training and development of clinical research staff in the pharmaceutical industry
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