Principal Clinical System Lead

As a Prinicipal Clinical System Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

As a Principal Clinical System Lead, working as a Decentralized Clinical Trials (DCT) Lead, exclusively assigned and embedded within a Pharmaceutical Company, you will;

Support the Sponsor’s eCOA clinical systems:

• Take leadership role in eCOA project implementation
• Lead study-specific eCOA technology deployment and management strategies for internal Global Integrated Clinical Trial Data Services 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
• Collaborate with Global Development Office (GDO) Training & Communications group to define and maintain a training strategy for technologies
• 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 IRT 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 GDO 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
• Provide guidance and training to internal team members, when needed

You are:

• 8+ years of relevant experience in a Clinical Research technology-related role within the Pharmaceutical, CRO, or technology vendor industries.
• Experience with technology evaluation, deployment, and project management.
• Strong knowledge / experience with eCOA systems and their function within clinical trials.

 What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.