eCOA Project Manager

ICON Strategic Solutions; Wentworth's Location (NH); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Various annual leave entitlements

Health insurance offerings

Flexible country-specific optional benefits

Job summary

A leading strategic solutions company is seeking an experienced eCOA Project Manager. This role involves managing Electronic Patient Reported Outcomes technologies and engaging with stakeholders to implement solutions efficiently and with high quality. The ideal candidate has over 5 years of experience in Clinical Technologies, strong project management skills, and a collaborative approach to work.

Qualifications

• 5+ years of experience including 2 years in Clinical Technologies.
• Good understanding of clinical study management and regulatory operations.
• Familiarity with eConsent concepts.

Responsibilities

• Work autonomously on assigned work items and as a member of an interactive team.
• Develop and execute processes related to ePRO and eConsent.
• Engage with external resources as needed to develop Patient Technology functions.

Skills

Clinical Technologies

Project management

Stakeholder engagement

Regulatory operations

Communication

Education

Degree in a scientific, technology and/or business discipline

Job description

Overview

Join to apply for the eCOA Project Manager role at ICON Strategic Solutions. 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 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 role works as a member of the Patient Technologies (PT) team, a division of Information Management, to support process, policy and resources for usage of assigned technologies by clinical study teams. The role may take ownership of sub-projects within the initiative, engaging stakeholders and customer groups to enable study teams to implement ePRO in clinical studies efficiently, consistently and with high quality and low regulatory risk.

Responsibilities

• Work autonomously on assigned work items and as a member of an interactive team.
• Develop and execute processes related to ePRO, eConsent and related patient technologies.
• Source stakeholder input and initiate, develop and maintain process and technology tools as required.
• Provide support to Information Management and Global Product Development teams; interact with Business/Research Units to identify needs for ePRO and Mobile Health support.
• Help standardize elements of ePRO, eConsent and mobile usage across the portfolio; participate in initiatives to improve processes.
• Engage external resources as needed to develop internal Patient Technology functions and support.
• Conduct independent needs-based research to align technology implementation with sponsor rules and regulatory requirements.

Qualifications

• Degree in a scientific, technology and/or business discipline, with 5+ years of experience including 2 years in 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; experience with project/resource management, and strong verbal and written communication.
• Ability to manage multiple contacts and relationships at various levels; strong collaboration across departments.
• Understanding of business process re-engineering and implementation planning; self-starter who can work independently and adapt to teams with varying technical experience.
• Knowledge of current technology trends and their impact on patient technology implementation within a sponsor organization.
• Ability to stay informed on regulatory and technical trends affecting patient technology in large sponsor environments.

What ICON Can Offer You

ICON prioritizes a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers a range of benefits designed to be competitive within each country and focused on well-being and work-life balance for you and your family.

• Various annual leave entitlements
• Health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings
• Global Employee Assistance Programme with 24-hour access to a network of professionals
• Life assurance
• Flexible country-specific optional benefits (childcare vouchers, bike schemes, gym discounts, travel passes, health assessments, etc.)

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

ICON is committed to creating an inclusive environment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you need a reasonable accommodation for any part of the application process or to perform essential functions, please let us know through the form below.

Reasonable accommodations

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