Clinical Trial Management / Sponsor Oversight / TMF Management

3/2018 – 10/2019

• Implement eTMF including SOP authoring and training of users
• Maintain the process framework for TMF management and life-cycle management
• Support trial management teams in setting up, maintaining and archiving TMFs according to regulatory requirements using different business models (eTMF at Sponsor, eTMF at CRO, paper TMF at CRO)

Gute Klinische Praxis, Klinische Forschung

9/2015 – 3/2018

• Accountable for all aspects of assigned clinical trials (phase I and phase III) including successfully leading the trial management team
• As member of the working group: 'risk-based approach – tools and frameworks in clinical operations', development and implementation of a process and associated tools for a risk-based approach in clinical trial management and sponsor oversight
• Author of the SOP 'trial management and sponsor oversight of clinical trials', the sponsor oversight plan template and further supportive documents to this SOP as well as development of training materials and execution of classroom trainings

Gute Klinische Praxis, Klinische Forschung, Projektmanagement

9/2013 – 9/2015

• Responsible for providing operational support to study teams throughout all phases of clinical study management
• Ensure accordance with the appropriate quality standards including ICH/GCP as well as applicable regulations
• Giving support to the Global Operations Study Leader in designated management tasks

Gute Klinische Praxis, Klinische Forschung

4/2006 – 8/2013

• Accountable for delivering effective and efficient early development clinical trials (including First in Man) of assigned medicinal product in accordance with appropriate quality standards including ICH/GCP and applicable regulations
• Provide operational expertise and leadership to the clinical operations team ensuring the efficient and effective delivery of all operational aspects of assigned clinical trials
• Ensure accordance with the appropriate quality standards including ICH/GCP and applicable regulations

Gute Klinische Praxis, Klinische Forschung, Projektmanagement

9/2002 – 3/2006

• Local trial management in Germany and Switzerland of international phase II and phase III trials as well as investigator-initiated trials
• Responsible person for all clinical trial activities in Switzerland
• Responsible for trial data quality and delivery of commitments regarding timelines and patient numbers
• Conducting country feasibilities
• Responsible for budget adherence
• Coordination of CRAs and Local Trial Managers
• Developing country specific SOPs and training of internal staff

Gute Klinische Praxis, Klinische Forschung, Projektmanagement

2/2001 – 8/2002

• Monitoring of international and national oncological trials phase III
• Project management and CRA coordination of an international phase III trial

Gute Klinische Praxis, Klinische Arbeiten, Klinische Forschung