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IRT Manager, Clinical Supply Systems

ManagerManagerOtherRemoteSeniorTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

New Jersey + 1 moreAll locations: New Jersey | North Carolina

Posted

110 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglishGCP

Job Description

IRT Manager, Clinical Supply Systems

ICON plc

• 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.

Job 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.

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