Principal Clinical System Lead (Decentralized Clinical Trials Lead)

Job title: Principal Clinical System Lead (Decentralized Clinical Trials Lead)

About the Role As a Principal Clinical System Lead, you will provide strategic leadership for the design, development, and implementation of eCOA clinical systems and technologies, embedded within a sponsor company in a Decentralized Clinical Trials model.

What You'll Do

• Lead study-specific eCOA technology deployment and management strategies for internal stakeholders and external service providers.
• Collaborate with Clinical Supplies, Biostatistics, Vendor Management, and Procurement in sourcing, evaluating, and qualifying eCOA vendors.
• Act as the sponsor eCOA SME and project manager for study deployment projects.
• Lead study teams in developing study-specific user requirements specifications documents and UAT protocols; ensure Good Documentation Practices are followed.
• Provide support to study teams to resolve eCOA issues during the conduct of the study.
• Collaborate with protocol development to understand requirements for eCOA technologies; streamline data flow between eCOA and CTMS, Data Warehouse, Clinical Gateway, and Clinical Supplies Management System.
• Manage operational delivery with eCOA service providers; collect issues and trends; work with Vendor Management and vendors for resolution and prevention.
• Ensure training programs for internal staff and oversee standards on system design and data reporting.
• Direct activities of eCOA vendors, overseeing timelines and budgets; coordinate evaluation and impact of changes in the eCOA landscape.
• Support audit-related issues for eCOA services; ensure audit/inspection observations are remediated with the study team.

What We're Looking For

• 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 Pharmaceutical, CRO, or technology vendor industries.
• Strong knowledge/experience with eCOA/ePRO systems and their function in clinical trials.
• Experience with eConsent/Telehealth/Connected Solutions is preferred.
• Proven leadership with cross-functional teams and projects; excellent communication and interpersonal skills.
• Detail-oriented with strong analytical and problem-solving abilities; experience with technology evaluation, deployment, and project management.
• Willingness to travel around 15%.

Nice to Have

• Experience with eConsent/Telehealth/Connected Solutions is preferred.

Compensation & Benefits

• Competitive salary and benefits; various annual leave entitlements; health insurance options; retirement planning; global Employee Assistance Programme with 24/7 support; life assurance; flexible benefits by country, including childcare vouchers, gym discounts, travel subsidies, and health assessments. ICON promotes inclusion and belonging and provides an accessible, discrimination-free workplace.