Roman Grunwald

• Provides comprehensive operational support for FMI’s participation in clinical trials sponsored by BioPharma partners, Academic partners, and FMI led trials • Developing, implementing, and monitoring the execution plans for the clinical studies they support from initial study intake through final project deliverables • Proactive, clear, and customer-centric communication, day to day project management, as well as, operational excellence and oversight of clinical trials.

Lead of a International ClinOps Management Team on clinical trials including: • Actively participates in Project meetings, providing up-todate and concise information on study progress from the clinops perspective, identifying field operations issues that require input from the Team • At international level, coordinates, oversees and report on the local/regional Clinical Operations Project Managers to ensure that study-related activities are conducted according to expected quality, timelines and budget

Project Management of non-interventional studies (NIS) and clinical trials including: • Study coordination in collaboration with a team of PMs, CRAs and CTAs • Coordination and execution of contractual negotiations with the study sites • Administration of payment processes • Compliance with budget and time schedule

- Clinical research activities in clinical trials (Phase II), including: • Assuring compliance with local regulations, Code of Federal Regulations (CFR) / International Conference of Harmonization (ICH) and GCP guidelines, company and Sponsor SOPs • Preparation of study submissions to Competent Authorities & Ethic Committees and further processing as applicable

Clinical Research & Project Coordinator in clinical trials (Phase I, II & IV) and NIS including: • Controlling and coordinating of the Clinical Research Associates & Project Assistants in the implementation of multinational study-related activities • Preparation, initiation, monitoring and close-out of blinded clinical trials of phase I-IV

Clinical research activities in clinical trials (Phase I, II & III), including: • Performing and organizing of feasibilities for planned studies • Preparation, initiation, monitoring and close-out of blinded and unblinded clinical trials of phase I-III • Review and verification of clinical study data Monitoring the proper conduct of clinical trials in accordance with the legal requirements, the protocol, SOPs, WPDs, ICH-GCP-, FDA - and Sponsor guidelines

Tätigkeit im Bereich Medizincontrolling & Qualitätsmanagement: - Überprüfung und Kontrolle der DRG-Kodierung - Planung des Jahresbudgets - Qualitätssicherung - Fort- / Weiterbildung von Mitarbeitern im DRG-System - Bewertung von MDK-Gutachten

- Medizin - Statistik - Dokumentation - Programmierung

Betreuung von Menschen mit Behinderung im Arbeitsalltag

- Chemie - Mathe