Manager, Clinical Systems - Remote

Overview

The Manager of Clinical Systems oversees the planning and execution of clinical system processes, ensuring compliance and promoting continuous improvement within the company.

In Short

• Manage end-to-end clinical system processes.
• Act as a Subject Matter Expert for clinical system operations.
• Ensure compliance with regulatory standards and SOPs.
• Generate and report KPIs and metrics.
• Collaborate with IT and vendors for system implementation.
• Lead development of processes and training materials.
• Support archiving activities.
• Provide training and support for clinical system users.
• Execute change management activities.
• Identify and resolve performance issues.

Requirements

• Bachelor's Degree or equivalent experience.
• 5-8 years of clinical systems management experience.
• Experience with Veeva Vault platform preferred.
• Knowledge of GCP and ICH Guidelines.
• Strong software skills, including Microsoft Office.
• Excellent communication and organizational skills.
• Ability to work independently and as part of a team.
• Experience in project management within biotech or pharmaceutical settings.
• Knowledge of regulatory compliance regulations.
• Demonstrated Apogee's C.O.R.E. values.

Benefits

• Great company culture based on C.O.R.E. values.
• Fast-paced and dynamic work environment.
• Competitive compensation and benefits package.
• Flexible PTO.
• Company-wide shutdowns twice a year.
• Commitment to professional growth and development.
• Regular in-person team meetings.