Martina Kirsch

Dedicated versatile operations professional with 20+ years in global CROs, driving activities from study award to study closure across multiple therapeutic areas and study phases. I am the right person to get projects back on track. Hands-on leader with a strong commitment to collaboration, accountability, and operational excellence.

Successfully delivering activities from study award to study closure for clinical trials and non-interventional studies of phases II – IV across 10 – 20 countries spanning oncology, neurology, cardiology and other therapeutic areas while maintaining client timelines and quality standards. Driving portfolio performance through proactive resource planning, forecasting and financial oversight. Strengthening study conduct capabilities through development and delivery of targeted training.

Supporting business growth through proposal strategy development and successful bid defense participation. Building strong internal and external stakeholder relationships.

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.

Master Of Drug Regulatory Affairs - M.D.R.A. - Rheinische Friedrichs-University Bonn (2014-03 - 2016-09)

Bioscience Information Specialist - Dipl.-Dokumentarin (FH) - University of Applied Sciences and Arts (2001-09 - 2005-08)