Associate Study Start-up Delivery Director - IQVIA Biotech - Remote | Allensbach, Germany
(2022-05 - 2026-10)
- Drove strategic oversight and delivery of the end-to-end study start-up process, including site selection, regulatory submissions, site contracting and budgeting, and site activation for 50 to 400 sites of phase II – III clinical trials across 10 – 20 countries in Europe, Australia, and the USA for small, mid-size, and large biotech clients.
- Managed financials, forecasting, resource allocation, utilization, and operational performance.
- Implemented early warning controls to mitigate potential roadblocks to the successful completion of startup and maintenance activities.
- Contributed to business growth through client-facing bid defense presentations.
- Led and mentored international Study Start-Up Manager teams.
Site Start-Up Project Delivery Manager - Syneos Health - Remote | Allensbach, Germany
(2020-03 - 2022-05)
- Coordinated the end-to-end start-up process, including site selection, regulatory submissions, site contracting and budgeting, and site activation for 300 to 600 sites across 20–35 countries in Europe, Asia-Pacific, Latin America, and the United States for top 10 pharmaceutical clients.
- Handled start-up financials, forecasting, and resource planning.
- Led and mentored international Study Start-Up Manager teams.
- Supported business development through bid defense presentations.
Senior Global Regulatory Affairs CMC Scientist - ICON plc - Constance, Germany
(2018-05 - 2019-10)
- Compiled strategic- and content-related CMC documentation (modules 1, 2.3 and 3) for variations and renewals for biological and chemical products across 25+ markets (EU, EEA, CIS, NEMEA) including coordination and compilation of responses to authority deficiency letters.
Global Regulatory Affairs Lead - ICON plc - Mannheim, Germany
(2015-01 - 2018-05)
- Led clinical trial applications for global phase II to IV trials across 15 to 30 countries in Europe, Asia-Pacific, and the United States from study award through maintenance to study closure.
- Managed study budget, forecasting, resource planning, and operational performance to meet client and organization targets.
- Compiled regulatory dossiers and ensured compliance with regional requirements.
- Led multicultural teams of Local Regulatory Affairs Associates and Leads.
Operational Team Lead - ICON plc - Mannheim, Germany
(2012-04 - 2015-01)
- Directed operational activities from study start-up to database closure for Post-Authorization Safety Studies, Drug Utilization Studies, and non-drug registries spanning 500 to 3,000 sites across 10 to 30 countries for top 10 pharmaceutical clients.
- Handled study budget, forecasting, and resource planning.
- Led and mentored teams of Site Management Associates and Clinical Research Associates.
Lead Site Management Associate - ICON plc - Mannheim, Germany
(2010-07 - 2012-04)
- Coordinated site management activities for global non-interventional Post-Authorization Safety Studies, long-term registries and data cohorts for drugs and medical devices across 15 to 25 countries in Europe, Latin America, and the USA.
- Delivered training and workshops on study management and Electronic Data Capture (EDC) systems to Investigators, Study Nurses, and Study Coordinators at Investigator Meetings.
- Led and mentored international Site Management Associate teams.
Site Management Associate 2 - ICON plc - Mannheim, Germany
(2007-08 - 2010-07)
- Conducted site recruitment, regulatory submissions, site contract negotiations, protocol and system training for Investigators and Study Nurses on non-interventional trials; performed PSVs, SIVs, IMVs, and COVs remotely.
- Submitted applications to CECs, LECs, and regulatory authorities across Europe.
- Provided hands-on support to site staff in data entry, query management, and adverse event reporting until last investigative site closure; served as EDC expert for cross-functional internal teams and clients.
Project Data Manager - AB Cube Germany GmbH - Munich, Germany
(2006-01 - 2007-01)
- Responsible for eCRF design, GCP system validation, and EDC training development for clinical trials and non-interventional studies.
