Careers

The Systems Manager role includes analyzing, implementing, managing, networking and collaboration with internal and external clients to ensure quality deliverables throughout all phases a clinical trial. Systems Managers are responsible for overseeing and leading groups of people and projects to meet business and regulatory requirements.  Systems and computer skills along with strength in ability to problem-solve, be attentive to details and provide clear written and oral communication is critical to this roll.

Role and Responsibilities

Responsible for contributing to and implementing  key services to our clients through systems knowledge, support and integration. 

• Assure systems are properly implemented and operating to achieve and maintain GxP validation, including the review of validations documentation, testing and coordinating change management.
• Collaborate with user to establish operational workflows and create/provide user training.
• Develop electronic clinical systems strategy to support trial execution and oversight.
• Oversee strategy, management and integration of electronic TMF systems, including vendors and technology.
• Partner with stakeholders in defining business needs, project planning, vendor selections, development, deployment and end user adoption to provide ongoing management and functional oversight for all electronic clinical systems.
• Serve as Subject Matter Expert (SME) for clients and team for support, system and database asministration on the clinical database.
• Manage eTMF transfers and migrations in compliance with regulatory requirements
• Support the development of systems metrics reporting 

Qualifications and Education Requirements

• Experience leading small teams
• Experience working with a variety of Systems
• Experience with User Acceptance Testing and Systems Validation
• Bachelor Degree or other professional degree preferred