eCOA Project Manager
ICON plc
Job Level
Mid-LevelSenior
About the role
- Assist in the implementation and management of Electronic Patient Reported Outcomes (ePRO) and other related Patient technologies throughout Global Product Development
- Work as a member of the Patient Technologies (PT) team to assist in the development of process, policy and resources for usage of assigned technologies by clinical study teams
- Take ownership of sub-projects within the overall initiative, engaging a variety of stakeholders and customer groups to ensure study teams are enabled to implement ePRO in clinical studies efficiently, consistently and with the highest quality and lowest regulatory risk
- Consideration of technologies allied and parallel to ePRO and research allied technologies and vendor services
- Serve as support resource to Information Management and Global Product Development colleagues and interact with Business/Research Units to identify specific needs
- Identify, initiate, and support solutions that allow study teams to implement ePRO and other patient-based technologies
- Participate in and may lead initiatives to standardize elements of ePRO, eConsent and Mobile usage across the portfolio
- Assist and manage key components of eConsent roll-out activities including the development of best practices and process improvement
- Engage external resources as required to develop internal Patient Technology functions and support
- Support rapid response, audit and inspection and conduct independent needs-based research to expand Patient Technologies’ knowledge
Requirements
- Degree in a scientific, technology and/or business discipline
- 5+ years of working experience including 2 years of experience with Clinical Technologies
- Good understanding of the processes associated with clinical study management, data management, and regulatory operations
- Familiarity with eConsent concepts and best practices
- Demonstrated project management skills
- Project management, resource management (staff and financial), administrative, and technical capabilities
- Effective verbal and written communication skills
- Ability to manage multiple contacts and relationships at various levels throughout the organization
- Understanding of business process re-engineering and implementation planning
- Team player with good oral and written communication skills
- Talent for training/presentation
- Self-starter who is able to work independently and willing to provide original thinking
- Adaptable and able to work with study teams with disparate levels of technical experience
- Understanding of current technology and how it could be used to facilitate growth toward overall corporate goals
- Ability to keep abreast of current regulatory and technical trends and how these trends would impact patient technology implementation within a large sponsor organization
