Syreon Corporation

Clinical Operations

• Manage the study team to ensure all deliverables are met via project team meetings and ad hoc discussions
• Be the primary point of contact for the Study Sponsor and lead study teleconferences
• Develop study documents including Project Plans and Risk Management Plans
• Review study documents from other departments such as CRFs, Data Management Plan, Data Validation Document, CRF Completion Guidelines, Safety Management Plan, Statistical Analysis Plan, Clinical Study Report
• Review study protocols, informed consent templates and prepares Central Ethics Boards submissions and resubmissions as required
• Planning, coordination, and presentation at Investigator’s Meeting(s)
• Set-up, collect, and maintain Trial Master Files
• Set-up and distribution of Site Investigator Binders
• Recruits, trains, and provides ongoing support to participating sites, study monitors, Sponsors, and third-party vendors
• Development and execution of Site Recruitment strategies
• Review of monthly study pass-thru account statements and study budgets to ensure adherence to budget
• Reviews study database and processes in collaboration with data management team, as required

Clinical Project Manager