Associate Director, Clinical Operations Standards and Planning

Role Summary

We are seeking an Associate Director, Clinical Operations Standards and Planning to join our Clinical Operations Team. This position will be responsible for the identification, documentation, maintenance and optimization of Apogee Clinical Operations standards and best practices to support a growing portfolio of global clinical trials. This position will lead the Clinical Operations organization to identify innovative strategies to increase operational efficiency across programs. Additionally, this role will provide oversight of the Clinical Operations resource planning process to support the Clinical Operations Leadership Team in ensuring appropriate resources are available at the right time to support the Apogee portfolio. This role will report into the Executive Director Process and Strategic Planning and will be a key leader within the Clinical Trial Excellence Team.

Key Responsibilities

• Identify operational efficiencies for Apogee in partnership with key CROs and vendors and implement solutions to support delivery of Clinical Trial Operations team
• Partner with key stakeholders including Clinical Trial Operations, Vendor and Strategic Management to ensure vendor performance aligned with Apogee expectation
• Proactively identify and maintain standards to ensure consistency across all programs and studies for operationalizing global clinical trials working with assigned CRO’s
• Collaborate with Apogee Process Excellence and QA organizations to ensure that study level operations can be standardized in line with vendor processes to ensure operational efficiency and inspection readiness
• Oversee Clinical Operations Resource Planning and Management to ensure efficient utilization of resources across the organization
• Support the Clinical Operations Leadership Team (COLT) in establishing and maintaining a defined career ladder to support employee growth and scalability of an expanding organization
• Develop, coordinate and maintain operational best practices for key activities