The eCOA Operations Lead serves as a functional subject matter expert (SME) in the field of electronic Clinical Outcome Assessments (eCOA), driving process optimization, standardization, and operational excellence across clinical programs. This role collaborates closely with internal partners, such as Global Clinical Operations, Clinical Development, HEOR, Program Management, Quality, Legal and Regulatory Affairs, as well as external partners (CROs, eCOA Vendors, etc.) to enhance efficiency and effectiveness in eCOA implementation across the portfolio.

By providing strategic oversight, governance, and continuous process improvements, the eCOA Operations Lead ensures eCOA solutions are seamlessly integrated, efficiently deployed, fully compliant with regulatory requirements, and enhance the patient and site experience to ensure an optimal level of robustness for data captured via eCOA.

Strategic Leadership & eCOA Framework Development

• Lead cross-functional teams in the development, optimization, and execution of eCOA frameworks to ensure efficiency, compliance, and seamless trial execution.
• Serve as an eCOA SME across the organization, providing expert guidance throughout the end-to-end (E2E) process to ensure best practices and regulatory compliance.
• Establish and maintain governance and operational models to drive eCOA standardization, ensuring global consistency across the portfolio.
• Develop KPIs and metrics dashboard and conduct Portfolio Oversight Meetings with CROs and third-party vendors to proactively monitor performance, resolve challenges, and continuously enhance eCOA implementation strategies.

Process Optimization & Documentation

• Develop and implement process documentation and oversight frameworks for eCOA governance, ensuring alignment with regulatory expectations and internal quality standards.
• Establish and maintain a centralized eCOA portal, facilitating knowledge sharing, resource accessibility, and ongoing landscape monitoring.
• Oversee third-party vendors for copyright, translations, and library services, ensuring compliance with licensing agreements and regulatory requirements.

Training & Stakeholder Engagement

• Design and implement a comprehensive training program to enhance internal expertise on eCOA processes, compliance requirements, and industry best practices.
• Drive patient and site engagement strategies by embedding structured journey mapping templates (enabling evaluation of protocol-specific eCOA processes) and tailored training initiatives, ensuring an optimized patient & site experience.
• Provide ongoing internal advisory support to key stakeholders, offering insights on eCOA advancements, challenges, and evolving regulatory landscapes.

Regulatory Compliance & Inspection Readiness

• Ensure continuous regulatory inspection readiness, maintaining complete documentation (including eCOA training), audit trails, and compliance with global regulatory requirements (ICH-GCP, FDA, EMA, and industry guidelines).
• Stay ahead of eCOA industry trends, regulatory updates, and technological advancements, proactively adapting strategies to maintain compliance and competitive advantage.

SKILLS AND COMPETENCIES

• Expert knowledge of eCOA methodologies, regulatory guidelines (ICH-GCP, FDA, EMA), and industry best practices.
• Deep understanding of eCOA systems, technical implementation, and operational workflows.
• Strong analytical skills and attention to detail to identify and resolve issues proactively.
• Ability to work independently and cross-functionally, lead complex initiatives with minimal oversight, and effectively influence change.
• Excellent communication, stakeholder management, and interpersonal skills.
• Fluent in English (written and spoken).

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Master’s or Bachelor’s degree in Life Sciences, or a related field, or equivalent experience.
• Minimum 8 years of experience in clinical trials within the pharmaceutical or biotechnology industry, with direct eCOA implementation responsibilities.
• Proven expertise in system implementation, vendor management, and process development of eCOA.
• Strong project management and leadership skills, with a track record of driving operational efficiency.
• In-depth understanding of clinical development processes and regulatory frameworks governing eCOA solutions.

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.