Martina Kirsch

- Lead end-to-end study start-up and site activation for global multi-regional clinical trials and multi-protocol programs across 10 – 20 countries, overseeing feasibility, country strategy, contracts, and regulatory submissions. - Own portfolio financials, including budget management, forecasting, resource planning, and operational performance. - Conduct monthly portfolio reviews to monitor financial health, resource allocation, risks, and client satisfaction, and improving forecast accuracy.

- Directed study start-up activities from site selection to site activation readiness for multi-regional projects and multi-protocol programs across 20 to 35 countries. - Managed budgets, forecasting, resource planning, utilization, and operational performance. - Led and mentored multicultural teams of Study Start-Up Managers, improving delivery consistency and reducing escalations. - Supported business development through Request-For-Proposal preparation and Bid Defense presentations.

- Compiled strategic- and content-related CMC documentation (modules 1, 2.3 and 3) for variations and renewals of biological and chemical products across 25+ markets (EU, EEA, CIS, NEMEA). - Coordinated and compiled responses to authority deficiency letters while ensuring timely approvals.

- Led clinical trial applications for global clinical trials of phases I to IV across 15 to 30 countries (Europe, Asia Pacific, and Rest-Of-The-World) from study award through maintenance to study closure. - Managed budget, forecasting, resource planning, and operational performance. - Compiled regulatory dossiers and ensued compliance with regional requirements. - Oversaw multicultural teams of Local Regulatory Affairs Associates and Leads. - Request-For-Proposals and Bid Defenses.

- Managed operational activities from study start-up to stuy database closure for Post-Authorization Safety Studies, Drug Utilization Studies, and non-drug registries with 500 to 3000 sites across 10 to 30 countries. - Developed feasibility questionnaires and report templates for SIVs, IMVs, and COVs. - Owned study portfolio financials, including budget management, forecasting, resource planning, and operational performance. - Oversaw Site Management Associates and Clinical Research Associates.

- Led 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. - Created interim and final reports for Ethics Committees and Other Authorities. - Delivered trainings and workshops about study management and Electronic Data Capture (EDC) systems to Investigators, Study Nurses and Study Coordinators at Investigator Meetings. - Mentored Site Management Associates.

- Conducted site recruitment, site contract negotiations, protocol and system trainings for Investigators and Study Nurses for non-interventional trials. - Submitted clinical trial 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. - Acted as EDC expert for cross-functional teams and clients. - Developed data management and EDC trainings.

- Created eCRFs for clinical trials and non-interventional studies using SQL and XML. - Developed and delivered EDC trainings to colleagues and clients. - Built software demonstrations to support Sales. - Contributed to GCP system validation.

Medizinische Dokumentation, Informatik, Statistik