Description
Overview:This role is responsible for overall coordination of all clinical activities.Essential Duties:
-
Manage the design, process and evaluation of clinical studies consistent with applicable regulations and guidelines -
Prepare and revise study protocol, CRFs, IFU, etc -
CRO and vendor management including budget negotiations and site selection -
Determine study objectives, strategy and scope to meet business needs -
Prepare technical reports and data analysis on clinical trial results -
Work closely with Regulatory Affairs on new or expanded device approvals/clearances
Requirements:
-
BS or RN; higher levels of education preferred -
10+ years clinical research experience in medical device industry -
Management experience in the development and implementation of clinical protocols for cardiology and interventional radiology products -
Prior product development experience -
Working knowledge of ICH GCP guidelines -
Strong communication and organizational skills
To find out more about Real please visit www.realstaffing.com