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 Patient technologies throughout Global Product Development
- Work as a member of the Patient Technologies team to develop process, policy and resources for assigned technologies
- Take ownership of sub-projects, engaging stakeholders and customer groups to enable efficient, consistent, high-quality ePRO implementation
- Serve as support resource to Information Management and Global Product Development colleagues and interact with Business/Research Units
- 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 ePRO, eConsent and Mobile usage across the portfolio
- Research allied technologies and vendor services and assist in developing future vision for patient-based technology usage
- Assist and manage key components of eConsent roll-out activities including best practices and process improvement
- Support rapid response, audit and inspection activities and engage external resources as required
- Conduct independent needs-based research to expand Patient Technologies’ knowledge and ensure regulatory compliance
Requirements
- Degree in a scientific, technology and/or business discipline
- 5+ years of working experience including 2 years of experience with Clinical Technologies
- Expertise in process development and execution
- Experience with Mobile Technologies, Mobile App usage and Deployment, PRO technologies
- Knowledge of Process Management and Change Management
- Familiarity with eConsent concepts and best practices
- Experience with Medical Devices related to patient technologies
- Good understanding of the processes associated with clinical study management, data management, and regulatory operations
- 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 ability to self-motivate on assigned sub-projects
- Talent for training/presentation and adaptable to disparate technical experience levels
- Ability to keep abreast of current regulatory and technical trends
