Decentralized Clinical Trials Lead
About the role
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
What You Will Do:
- 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
- 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%)
- Variety of annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others
Your Profile:
What ICON can offer you:
Senior Talent Acquisition Business Partner
ICON Strategic Solutions
Day in the life
Teaser label
Content type
Blogs
Publish date
05/30/2023
Summary
Clinical research is the backbone of the life sciences industry. In fact, the established processes used to accurately trial and research medical, surgical and behavioral intervention are
Teaser label
Clinical trials are an exciting space to start or progress your career, but what do you need to succeed?
Teaser label
Our People
Blogs
Publish date
04/19/2023
Summary
ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology, and medical device industries. Project managers at ICON play a crucial role in ensuring the success of clinical trials.
Teaser label
Jeroen Kleijne, a Project Management Director at ICON, describes what he thinks makes a project manager stand out.
Teaser label
Our People
Blogs
Publish date
04/29/2020
Summary
The role of Project Manager is essential in most industries yet many people are unsure of what the job entails. Project managers have diverse and plentiful responsibilities. Not only are you accountable for managing projects, but you also need to be a good communicator and collaborator.
Teaser label
Project Manager’s have diverse and plentiful responsibilities.
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