A pharmaceutic company specialized in development of inhibitors of tyrosine kinase in human medicine and veterinary, that conducts an important program in clinical development in oncology, inflamatory and neurodegenerative diseases (20 trials of phase II in France and 13 trials of phase III abroad) is looking for a Project Manager for the clinical trials.
Conception, implementation and coordination of clinical trials in collaboration with departments of Clinical Operations, Pharmacovigilance, Biometry and Medical Redaction:
Schedule the program of clinical development
Compose the protocols, modifications and reports of the trials
Compose regulatory dossiers
Manage the relations with the investigators and opinion leaders
Implement and supervise the mentioned actions to respect the terms of recruitment and good clinical practices.
Additional education in metodology (CESAM, DIU, …)
Sucessful experience of Project Management in clinical trials or pharmaceutic laboratory or in CRO
6 to 8 years of experience of clinical development (phases II and III)
Experience in oncology or in inflammatory and auto-immune pathologies will be a plus
Experience in international development is a must
Good knowledge of regulatory environment in clinical trials
Experience in redaction of study reports and regulatory dossiers for FDA (IND, NDA) and EMEA
Fluent English is a must
Please submit to email@example.com