The Institute for Clinical Investigation (ICI), member of Bionian Cluster, is currently looking to fill a Clinical Project Manager position.
JOB DESCRIPTION: Clinical Project Manager
Responsible for the support of assigned sites in accordance with Good Clinical Practice (GCP), ICH guidelines and federal regulations. Close collaboration with other members within Clinical Trial Management (CTM). May be responsible for monitoring assigned sites in accordance with GCP/ICH and SOPs and submitting the proper documentation to the national authorities for approval.
COORDINATION / COMMUNICATION, ADMINISRATION AND PERSONNEL DEVELOPMENT:
Ensure compliance with the application and communication of all company’s policies, procedures and fundamentals.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
• A Bachelor’s/MSc degree is required (science-related discipline strongly preferred, i.e. Pharmacology, Chemical Engineering, Biology etc.).
• A minimum of 3 years of clinical trial experience within pharmaceutical, biotechnology, CRO company and/or healthcare setting.
• Demonstrated computer skills (MS Office, Powerpoint)
• Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
• Direct expertise of site management and logistical execution of clinical trials for at least 2 years.
• Knowledge of GCP as relates to clinical trial management
• Previous on-site monitoring experience preffered.
• Excellent use of English.
Acting as a Contract Research Organization on behalf of the Biopharma Industry, Academic Centers, Investigators and other Public or Private Bodies, it offers services at any stage of development for marketing authorization of pharmaceutical products.
I.C.I., as a member of the Bionian Cluster, has established collaborations with globally renowned Universities, Research Institutes, state Institutions and Hospitals, a fact that enhances its presence on the international environment of CRO-companies.
The Institute for Clinical Investigation, modeled according to the General Clinical Research Centers in the USA and Europe, operates strictly according to the ICH- GCPs and the current legislation, regulations and guidelines οf the International and National organizations (FDA, MHRA, EMA, EOF). The multidisciplinary and highly skilled personnel of I.C.I. has been endowed with an extensive range of academic titles and qualifications, as well as a broad experience in bioequivalence, pre-clinical and clinical research.