NV Clinical Research Project Manager

MAIN JOB DUTIES/RESPONSIBILITIES (Please list most important duties first)

·         Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies. 

·         Assist in preparation of sections of the Investigational Plan for assigned clinical studies. 

·         Assist in preparation of study materials and/or training (e.g., training of investigators, site staff and Medtronic field staff). 

·         Interface with, and assure training of investigators, site staff, and Medtronic clinical staff. 

·         Conduct site initiation (e.g. start-up document preparation, distribution, receipt, and review).  Set-up and maintain accurate study status and implant logs. 

·         Conduct site monitoring

·         Interfaces with representatives from key functional groups (Research & Development, Manufacturing, Sales, Marketing, Regulatory Affairs, and European Clinical Groups). 

·         Assist in preparation of study budget and project plans. 

·         May arrange conference calls, staff meetings and training events. 

·         Assist in compilation and review of adverse event information. 

·         Assist in follow-up and resolution of site issues noted by field staff. 

·         Assist in compilation, review and conclusion of device complaints. 

·         Assist in study closure activities (e.g. close-out document preparation, distribution, receipt and review, audit and archive). 

·         Assist data management group with review of clinical data/information and oversight of data correction. 

·         Assist in preparation of annual, interim and final reports and presentations. 

·         Provide oversight of activities performed by Contract Research Organizations (e.g. CROs, core labs). 

·         Able to refer to Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs) for guidance on everyday study tasks. 

·         Participate in training to enhance knowledge base.