iota Biosciences, Inc. powered by Astellas

Clinical Operations

• Manage a high performing clinical operations team by providing direction, subject matter expertise, training and mentorship.
• Responsible for managing the design, development, modification, and evaluation of clinical execution plans (e.g., protocol, case report forms, consent forms, source document worksheets, budget, timelines, gap analysis, etc.)
• Accountable for the comprehensive clinical trial activities including but not limited to study start-up, site activation, site management, vendor oversight, study reports, site and study close-out.
• Provide technical direction to clinical research organizations (CROs) and oversee vendor selection/management as needed to execute clinical studies.
• Work closely with hospitals and investigators participating in clinical studies and maintain close working relationships with KOLs, other investigating physicians and site coordinators.
• Provide input and support for post-clinical activities and market launch of products.
• Establish / support cross-functional teams to ensure optimal alignment of Clinical, Regulatory, commercial goals, site operations, data monitoring and review, and safety surveillance and reporting expectations.
• Ensure clinical research programs are conducted in accordance with company standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulations.

Manager, Clinical Operations