Manager, Clinical Study Start-Up

General SummaryThe Manager of Clinical Study Start-Up leads the in-house Clinical Research Associate (ICRA) and Clinical Budget Analyst (CBA) teams and oversees study and site start-up activities, including regulatory documentation, site support tools, clinical site budgets, vendor management, and site activation. The role establishes and applies start-up best practices, represents Clinical Operations on cross-functional project teams, partners with our Clinical Study Management and Legal teams, and provides strategic and tactical leadership for Penumbra-sponsored clinical studies. This position is also responsible for hiring, coaching, mentoring, resource planning, and anticipating future staffing needs.   Specific Duties and Responsibilities• Lead a team that supports study and site start-up execution, amendment submissions and approvals, activation process, and final site closure activities. *• Lead or supervise development of study start-up materials, and other study documents, e.g., consent templates, questionnaire licensing, study manuals. *• Lead and oversee the preparation and negotiation of initial clinical trial budgets and budget amendments with clinical study sites... Click Apply to read the full job description.