08.11.2025 aktualisiert
100 % verfügbar
Senior Clinical Research Associate and Pharmaceutical Development Expert
Feldkirchen, Deutschland
Weltweit
Dr. rer. nat. habil Medizinische Biochemie, Dr. phil. PhilosophieÜber mich
• >22 Jahre Pharmaentwicklung (versch. Indikationen) • Senior CRA – GCP(R2) Zertifikat, Präklinik, Entwicklung/Klinische Phasen 1-4 • Führung mit Budgetzuständigkeit; Qualitätssicherung • Erarbeitung einer IB, Datenanalyse, Risikomanagement • Zusammenarbeit mit CROs: ADME, Pharmakologie, Toxikologie
Skills
GentechnikUnterrichtenHämatologieBiochemieBiotechnologieMolekularbiologieBiologieKardiologiePräklinische EntwicklungKlinische ForschungClinical Trial Management SystemComplianceDatenbankenKrankheiten und StörungenGute Klinische PraxisGeistiges EigentumIp-PortfolioProjektmanagementKrebsbehandlungMicrosoft ProjectPatentePulmologieTeam ManagementPharmazeutischen EntwicklungRegulatory AffairsAdministration von Datenbanken
Clinical Research and Development
Over 25 years of pharmaceutical development experience including fibrinolysis, anticoagulation, COPD, asthma, cardiovascular diseases, hematology, and oncology with expertise in CTMS and TrialMasterFile systems
ICH-GCP Certification and Training
Certified ICH-GCP EG R2 professional with extensive teaching experience for investigators and study team members in current and planned regulations
Project Management and Leadership
Organization, planning, and management of preclinical development phases with responsibility for team leadership, budget management, and collaboration with external partners
Regulatory Affairs
Experience with GCP/AMG studies phases I-IV from selection to close out, ethics and authorities submission, and regulatory compliance
Molecular Biology and Biochemistry
Expertise in molecular biology, biochemistry, and biological studies on blood stem cell differentiation
Gene Technology and Biotechnology
Project leadership in gene technology according to German law and experience with recombinant expression vector systems
Patent Law and Intellectual Property
Education and experience in patent law applications and intellectual property management
IT Systems and Database Management
Knowledge of MS Office, MS Project, iMedidata, clinical study software, and medicinal databases including ThomsonPharma
Over 25 years of pharmaceutical development experience including fibrinolysis, anticoagulation, COPD, asthma, cardiovascular diseases, hematology, and oncology with expertise in CTMS and TrialMasterFile systems
ICH-GCP Certification and Training
Certified ICH-GCP EG R2 professional with extensive teaching experience for investigators and study team members in current and planned regulations
Project Management and Leadership
Organization, planning, and management of preclinical development phases with responsibility for team leadership, budget management, and collaboration with external partners
Regulatory Affairs
Experience with GCP/AMG studies phases I-IV from selection to close out, ethics and authorities submission, and regulatory compliance
Molecular Biology and Biochemistry
Expertise in molecular biology, biochemistry, and biological studies on blood stem cell differentiation
Gene Technology and Biotechnology
Project leadership in gene technology according to German law and experience with recombinant expression vector systems
Patent Law and Intellectual Property
Education and experience in patent law applications and intellectual property management
IT Systems and Database Management
Knowledge of MS Office, MS Project, iMedidata, clinical study software, and medicinal databases including ThomsonPharma
Sprachen
DeutschMutterspracheEnglischverhandlungssicherFranzösischGrundkenntnisse
Projekthistorie
Working freelance for different national and international sponsors as Senior Clinical Research Associate, lecturer and trainer for ICH-GCP courses, project management in cardiovascular and respiratory diseases, hematology, ophthalmology, and diabetes
Co-founder of the biomedical company IBFB GmbH in Leipzig
Position Director in vivo Biology/project manager for preclinical and clinical phase 1a development including substance development and biological/biochemical testing of serine protease inhibitors
Zertifikate
ICH-GCP (R2)
ICON2023