CLINICAL TRIAL BUSINESS EXPERT

8/2015 – 8/2017

Strategic oversight of all global Trial Master File related operations
• Ensuring inspection readiness and Sponsor oversight; development and implementation of quality metrics and QC check guidelines
• Process improvement strategies; overseeing the migration of all studies into one single eTMF management system (Veeva)
• Development & maintenance of TMF SOP, TMF Plan and related business processes
• Manage vendor relationships including CROs in- and outside of the strategic partnering initiative (SPI), eTMF vendors
• Close cooperation with other departments, e.g. Medical Affairs, CQA, Drug Safety, O&C, Regulatory, CTS, CTRRD
• Overseeing archiving and off-site storage of study-related documents at Iron Mountain
• eTMF system training oversight
• Mentoring of TMF Managers and TMF Assistants
• Speaker at the European Trial Master File Congress, 09/2016
• Member of the “Site Leadership Team”
• Member of the “Creative Lab”

Pharmaforschung

1/2011 – 7/2015

Planning and conducting clinical trials as Associate Clinical Project Manager
• Implementation of SPI within UCB: streamlining of processes and SOPs with different strategic partners; SOP simplification initiative
• Spot award “silver” for extraordinary contribution to the company by the implementation of SPI
• Implementation of clinical trials from setup to clinical study report
• First contact person for CROs within and outside the scope of SPI
• Close cooperation with other departments, e.g. Medical Affairs, CQA, Drug Safety, O&C, Regulatory, CTS, CTRRD
• Strategic oversight of the entire operational study business
• Global coordination of the clinical site management
• Monitor- and site assessment visit
• Mentoring and training of (lead) CRAs
• Implementation of study requirements within the team, performance and quality control incl. CAPA management
• Ensuring Trial Master File maintenance by (SPI) partners, Sponsor oversight by performing regular QC checks and ensuring inspection readiness at all times
• Member of the “Site Leadership Team”
• Member of the “Creative Lab”

Projektmanagement

1/2011 – 12/2011

Operational team lead (Lead CRA) of an international CRA team
• Successful conduct of a license-relevant phase I study
• Spot award “gold” for extraordinary contribution to the company by regaining U.S market authorization for one product
• Contact person for project management
• Global Trial Master File Management
• Ensuring inspection readiness of the Trial Master File
• Coordination of study-related submissions to Ethics Committees (ECs) and competent authorities
• Implementation of study requirements within the team, performance and quality control
• Monitor and site assessment visits
• Co-monitoring and monitoring report review
• Mentoring of CRAs
• Training of CRAs and site personnel

Klinische Monitor (CRA)