DCT Lead
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.
