IRT Project Manager / Lead Clinical Systems Specialist
ICON plc · Blue Bell, PA · 3 wk ago
HybridFull-time
ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment driving innovation and excellence, and welcome you to join us on our mission to shape the future of clinical development.
Responsibilities
- Lead the implementation, configuration, and maintenance of clinical trial management systems (CTMS) and other clinical platforms.
- Collaborate with clinical and IT teams to ensure system functionality aligns with study protocols and operational requirements.
- Provide technical support and troubleshooting for clinical systems to ensure smooth operation and minimal downtime.
- Ensure system compliance with regulatory guidelines, including data security and privacy standards.
- Train and mentor users on clinical systems and best practices for data management and system utilization.
- Manage the planning, execution, and delivery of IRT projects, ensuring alignment with clinical trial requirements and regulatory standards.
- Collaborate with cross-functional teams, including clinical operations and technology specialists, to define project scope, objectives, and deliverables.
- Develop project plans, timelines, and budgets while monitoring progress to ensure successful project outcomes.
- Facilitate communication and stakeholder engagement to ensure transparency and address any project-related issues promptly.
- Stay current with industry trends and advancements in IRT technologies to drive innovation and improve project delivery.
Requirements
- Bachelor's degree in information technology, life sciences, project management, or a related field; advanced degree preferred.
- Extensive experience in managing clinical trial systems (e.g., CTMS, EDC, IWRS) and understanding of clinical operations workflows.
- Strong technical skills, with proficiency in system configuration, data integration, and troubleshooting.
- In-depth knowledge of regulatory requirements related to clinical data and system compliance (e.g., GCP, FDA 21 CFR Part 11).
- Excellent problem-solving, communication, and leadership skills, with the ability to manage cross-functional teams and complex projects with a focus on achieving project goals and timelines.
- Effective communication and interpersonal skills, enabling collaboration with diverse teams and stakeholders.
Benefits
- Various 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 support 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.
Visit our careers site to read more about the benefits ICON offers.