Digital Health Solutions Lead

Overview

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

Responsibilities

The role is responsible to provide operational leadership for eCOA and eSource deliverables, and to lead process oversight for clinical study and program level implementation. This includes responsibility for project management and technical leadership for the end-to-end study phases of setup, conduct, and closeout

What you will be doing:

• Execution of eCOA and eSource process capabilities at a study, program, and enterprise level. This may include oversight and process ownership for the following: vendor deliverables and timelines, defining data collection, reporting and mapping requirements, establishing study level dataflow, technology/app and device deployment, testing, dataflow and data change oversight and archival activities.
• Establishes process for cross-functional coordination for eCOA/eSource implementation in collaboration with study teams, eCOA/eSource service provider(s), translations providers, and COA Specialist.
• Organize eCOA/eSource related meetings with vendors and study teams in accordance with processes
• Oversight of risk assessments and mitigation strategies to ensure on-time delivery of eCOA and eSource capabilities
• Provides operational process oversight for eCOA/eSource vendors (Has a broad understanding of how source data come together, and/or how system vendors and solutions function to support the execution of the study)
• Has a comprehensive understanding and application of eSource principles and regulations and represents data standards, quality, and inspection readiness interests with key stakeholders and study teams.
• Ensures adherence with best practices, operational playbooks, guidance documents, SOPs, work practice documents, tools, databases, and standard templates for eCOA and eSource.
• Responsible for ensuring that all supporting operational documentation for studies/systems is maintained in accordance with processes to ensure quality, traceability, and regulatory compliance.
• Leads process improvement activities that support operational efficiencies.

Qualifications

You are:

• BS in Computer Science, Informatics, or life science discipline; demonstrated previous experience in pharma or CRO industry in either an eCOA or relevant Data Management role.
• Seasoned expert with eCOA implementation and experience with eSource solutions implementation (wearables, eConsent, videography, EHR to EDC etc.)
• Demonstrated knowledge of the Clinical Development Process
• Demonstrated mastery of relevant DM skills (e.g., defining data collection requirements, applying data integrity principles, database design, dataflow etc.) in multiple drug development programs, inclusive of all activities from program inception to regulatory submission.
• Demonstrated active contribution to inspections and major (vendor) audits.
• Expert knowledge of local and international regulations for clinical trials (e.g., GCP).
• Advanced understanding of data management processes
• Expert level understanding of data integrity principles and other associated industry and regulatory level best practices and requirements

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/benefitsAt ICON, inclusion & belonging are fundamental to our culture and values. 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, colour, 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-accommodationsInterested 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.