Decentralized Clinical Trials Lead

DCT Lead

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Principal Clinical System Lead, working as a Decentralized Clinical Trials Lead exclusively assigned and embedded within a Pharmaceutical Company, you will provide strategic leadership and direction in the design, development, and implementation of eCOA (electronic Clinical Outcome Assessment) clinical systems and technologies.

What You Will Do:

You will support the Sponsor’s eCOA clinical systems, taking a leadership role in eCOA project implementation, ensuring that deliverables meet quality, cost and timeline expectations.

Key responsibilities include:

• Lead study-specific eCOA technology deployment and management strategies for internal stakeholders and externally across functions and service providers

• Participate and collaborate with key process partners (e.g. Clinical Supplies, Biostatistics, Vendor Management, Procurement) in the sourcing, evaluation and audit/qualification of eCOA vendors

• Act as the sponsor eCOA SME and project manager for study deployment projects

• Lead study teams in development of study-specific user requirements specifications documents and user acceptance testing (UAT) protocols and execution. Ensure Good Documentation Practices are followed

• Provide support to study teams to resolve eCOA issues during the conduct of the study

• Collaborate with study teams during the protocol development process to understand requirements for eCOA technologies

• Effectively manage operational delivery with eCOA service providers; collect issues and trends from study teams; proactively work with Vendor Management and eCOA vendors for issue resolution and prevention

• Collaborate internally and with eCOA service providers to implement standards on both system design and data reporting

• Ensure the availability and delivery of training programs for relevant internal staff

• Collaborate with and supports other teams by streamlining data flow between eCOA and other systems (e.g. CTMS, Data Warehouse, Clinical Gateway, Clinical Supplies Management System)

• Ensure trust through transparency in communication and individual actions; ensure outcomes are organizationally driven rather than individually driven; promote collaborative organizational success

• Develop strategies to prioritize and deliver eCOA related initiatives in coordination with multiple internal departments

• Direct activities of eCOA vendors, ensuring compliance with specifications and the oversight of timelines and budgets

• Coordinate evaluation and impact assessment of changes in the eCOA landscape and makes recommendations for actions

• Provide support to teams on audit-related issues for eCOA services

• Ensure audit and inspection observations are evaluated and remediated in conjunction with the study team

Your Profile:

Required qualifications and experience:

• Bachelor's degree in computer science, information technology, or a related discipline
• 8+ years of relevant experience in a Clinical Research technology-related role within the Pharmaceutical, CRO, or technology vendor industries
• Strong knowledge / experience with eCOA/ePRO systems and their function within clinical trials
• Experience with eConsent/Telehealth/Connected Solutions is preferred for this position
• Proven leadership skills with the ability to effectively manage cross-functional teams and projects
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Detail-oriented with strong analytical and problem-solving abilities
• Experience with technology evaluation, deployment, and project management
• Willingness to travel as required (approximately 15%)

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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

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, color, 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 or submit a request here

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.

Are you a current ICON Employee? Please click here to apply