eCOA Project Manager

A Patient Reported Outcome (PRO) is a direct measurement of how a patient survives, feels or functions as a result of disease/illness and/or treatment. PRO feedback is always from the patient's (or caregiver’s) perspective with no interpretation from medical staff or others involved with a study.

This position is responsible for assisting in the implementation and management of Electronic Patient Reported Outcomes (ePRO) and other related Patient technologies throughout Global Product Development. The position would work as a member of the Patient Technologies (PT) team, a division of Information Management, to assist in the development of process, policy and resources for usage of assigned technologies by clinical study teams. The role will be required to 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 would also be required.

This role demands the ability to work both autonomously on assigned work items, as well as being a member of a strongly interactive team. Skill set of potential candidates must include expertise in process development and execution as well as the following areas:

• Mobile Technologies
• Mobile App usage and Deployment
• PRO technologies
• Process Management
• Change Management
• eConsent
• Medical Devices

In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.

Team:

• Work as a key member of the Patient Technologies Team to source stakeholder input and initiate, develop and maintain process and technology tools as required.
• Serve as support resource to Information Management and Global Product Development colleagues. Interact as directed with Business/Research Units to identify specific needs for ePRO and Mobile Health support

General

• Able to resolve conflicts, influence and communicate with key stakeholders and user groups
• Collaborate with key departments both within Global Product Development and across lines and divisions.
• Support rapid response, audit and inspection
• 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.
• Research allied technologies, vendor services and assist in developing expertise and forming a future expanded vision of patient-based technology usage.
• 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.
• Conduct independent needs-based research to expand Patient Technologies’ knowledge and determine how technology implementation fits within boundaries of the sponsor rules and federal regulations.

• Degree in a scientific, technology and/or business discipline, with 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 are required, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• 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, with the ability to self-motivate on assigned sub-projects as required.
• 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 

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.