Martina Kirsch

• Overseeing and managing the end-to-end site activation process (including pre-award/bid defense activities) including site identification, feasibility assessments, contract negotiations, and regulatory submissions. • Accountable for budget control, operational deliverables, resourcing, worked & forecasted units. • Monthly reviewing projects to control project health such as scope of work, performance, client relationship, budget and resources. • Mentoring Study Start-Up Managers.

• Managed study start-up activities from site selection through site activation readiness on multi-regional projects and multi-protocol programs in 20 to 35 countries. • Led a multicultural team of SSU Managers. Mentorship of Study Start-Up Project Delivery Managers. • Controlled study start-up budget against project milestones to ensure project profitability.

• Compiled strategic- and content-related CMC documentation (modules 1, 2.3 and 3) for variations and renewals of biological and chemical products in over 25 markets (EU, EEA, CIS, NEMEA) including coordination and compilation of responses to authorities’ deficiency letters

• Led clinical trial applications for global clinical trials of phases I to IV with 15 to 30 countries in EU, APAC and ROW from study award throughout maintenance until study closure. • Compiled regulatory dossiers for clinical trials. • Oversaw a multicultural team of Local Regulatory Affairs Associates & Leads. • Compiled regulatory strategies in Request-for-Proposals and presented those in bid defenses.

• Managed operational activities from study start-up until study database closure for Post-Authorization Safety Studies, Drug Utilization Studies, and non-drug registries with 500 to 3000 sites in 10 to 30 countries. • Developed feasibility questionnaires in collaboration with Scientific Affairs, report templates for SIVs, IMVs, and COVs. • Was accountable for budget control and vendor management. • Oversaw operational team members: Site Management Associates and Clinical Research Associates.

• Supported the Operational Team Lead and worked closely with Project Management. • Led site management activities on global non-interventional Post-Authorization Safety Studies, long-term registries and data cohorts with drugs and medical devices. • Created interim and final reports for Ethics Committees and Other Authorities. • Gave trainings on study management and led workshops for Investigators and Study Nurses & Coordinators on system trainings at Investigator Meetings.

• Conducted site recruitment for international non-interventinal studies including site contract negotiations, submissions to CECs, LECs, other authorities, protocol and system trainings for Investigators and Study Nurses inclusive query management until study closure. • Submitted clinical trial applications to CECs, LECs and regulatory authorities. • Acted as EDC expert for cross-departmental functions and clients. • Developed data management and Electronic Data Capture (EDC) trainings.

• Created eCRFs for clinical trials and non-interventional studies by using SQL and XML programming. • Developed EDC trainings and gave those to co-workers and clients. • Built software demonstrations to support Sales. • Supported GCP system validation.

Medizinische Dokumentation, Informatik, Statistik