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.
