Decentralized Clinical Trials Lead

ICON plc • Burlington, PE

5d

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. 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.

Requirements

• 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
• 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%)

Nice To Haves

• Experience with eConsent/Telehealth/Connected Solutions is preferred for this position

Responsibilities

• 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

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Principal