IRT Manager, Clinical Supply Systems
ICON plc
full-time
Posted on:
Location Type: Remote
Location: New Jersey • North Carolina • United States
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Tech Stack
About the role
- Establishes and maintains oversight of 3rd party IRT vendor.
- Works directly with study teams to gather requirements and ensure IRT system is developed in line with study protocol.
- Develops and manages system deployment timelines for IRT.
- Manages IRT documentation which include but is not limited to: requirements, user guides, training materials, and communication plans.
- Coordinates user acceptance testing.
- Manages the deployment of IRT applications with internal teams and contract vendor.
- Provides guidance related to contracted vendors’ functionality, performance, and processes.
- Works with Clinical Logistics and Biostats on the upload of key information (i.e., subject randomization and kit lists, etc.)
- Oversees routine meetings with contract vendor regarding performance, issues identification/resolution, and risk management.
- Confirm effective training plans for IRT systems are developed for clinical teams and site personnel with the contract vendor.
- If required, attend Investigator Meetings or CRA Trainings to discuss system functionality and requirements.
Requirements
- Minimum 5 years of relevant experience in the biotechnology/pharmaceutical industry, with minimum 3 years with direct IRT system development and management experience.
- Experience with direct IRT system design/configuration/development for clinical trials required.
- Working knowledge of the IRT terminology and computer programming terms.
- Through understanding of clinical trial protocol and translation of key parameters related to IRT system development.
- Knowledge of ICH/GCP and regulatory guidelines/directives
- Understands current and future business trends as related to IRT development field.
- Demonstrates high level of leadership and negotiation skills and Mentoring/coaching skills.
- Ability to effectively multi-task and prioritize work in a matrix environment to support multiple stakeholder priorities
- Effective problem-solving skills.
- Ability to work autonomously, manage ambiguity and act decisively while balancing speed, quality, and risk.
- Excellent written and verbal communication and presentation skills in small and large group settings.
- Excellent Project management and organizational skills.
- Effective Computer skills, with competency in MS Office Suite.
- Cross functional and cross-cultural awareness.
- Bachelor’s Degree in IT, Computer Science preferred.
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, 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
IRT system developmentIRT system designIRT system configurationclinical trial protocolICH guidelinesGCP guidelinesregulatory guidelinesproblem-solvingproject managementcomputer programming terms
Soft Skills
leadershipnegotiationmentoringcoachingmulti-taskingprioritizationautonomycommunicationpresentationorganizational skills