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%)

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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

Benefits may vary depending on role and location.

Visit our to read more about the benefits ICON offers.