Decentralized Clinical Trials Lead

ICON plc • Burlington, PE

8d • Remote

About The Position

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. 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.

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
• 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
• 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

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