Dr. Matthias Lendner

- Sponsor Initiated Audits - Management of European Trials - Head of the German Office - MPG Certification Trainer

- CPM for one European studies - Responsibilities: o Strategy development support o Development of study documentation o Reporting (SAE, MEDDEV, Safety Reports, CER) o Submissions, Amendments o Contract/budget negotiations o Site/Monitor Management o Sponsor communications

Within the Company I’m mainly focused on the German speaking countries (DACH region). Responsibilities within the Company: Regulatory: - Competent authority submissions - Ethic committee submissions - Compassionate use case submissions - Communication with CA and EC Administrative: - TMF maintenance according to ISO 14155 Annex E - Clinical trial agreement support Monitoring: - Site initiation visits - Interim monitoring visits - Close out visits - Audit preparation

- Betreuung von bis zu fünf Doktoranden und einer TA - Planung und Betreuung der einzelnen Projekte - Studiendurchführung - Laborleitung - Einwerben von Drittmitteln - Auftragsforschung - Diagnostik - Erstellen von SOP's - Projektleiter Gentechnik S2 - Lehre (Vorlesungen, Kurse) - Prüfungen (Staatsexamen)

Parasitologie (RNAi, Asthma)

- Parasitologie - Genetik

Biologie Chemie