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IRT Specialist

Parexel International Corporation

United States of America, Remote

Parexel FSP is looking for an IRT Specialist. Ideally, this candidate needs to be located near Rahway, NJ or West Point, PA.

IRT Specialist 

Description of Role & Responsibilities

  • Execute IRT systems development process from Kickoff to system go live, ongoing system change control, system closeout anddatabase lock activities.

  • Defines/redesigns IRT development processes across vendor base. Identifies areas for process improvement and leadsimprovement activities.

  • Creates and enforces the use of IRT systems standards. Responsibilities may include creation / revision of IRT systemsstandards, collaboration with vendors and internal stakeholders to define requirements, and monitoring standards utilization rate.

  • Performs peer-review of the IRT systems specific documentations for quality (e.g. comparing paper IRT measures withDeveloper version etc.)

  • Manages vendor performance and relationship(s). Responsibilities may include defining and implementing process with vendorrepresentatives, monitoring and analyzing vendor and Sponsor performance metrics, performing root cause analysis and identifying corrective actions, and serving as appoint of escalation for vendor issues

  • Serves as project manager of all IRT systems activities for protocols assigned.

  • Uses interpersonal, negotiating, and project management skills to perform the following tasks:

  • Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all IRT systems

  • Activity definition and sequencing, duration estimation, schedule development, and schedule control

  • Risk management planning (i.e. risk identification, analysis, and response planning as well as risk monitoring and control)

  • Communication planning, information distribution, performance reporting, and project closure

  • Obtains internal and external stakeholder feedback; this may include meeting with vendor project managers and/or meeting withsubject matter experts or representatives from stakeholder functional areas.

  • Provides support for successful integration of Sponsor and vendor systems.

  • Provides support for problem resolution between IRT vendors and Sponsor Clinical Trial Team.

  • May participate in training and education for stakeholders. May develop, or assist in development of, reference and/or trainingmaterial. May provide cross-functional internal and external communication as needed.

  • May provide support for the development / maintenance of relevant documentation, including applicable SOPs, job aids, andguidance documentation.

  • May mentor new staff.

  • May lead a continuous improvement special project or any other project or perform any other IRT related task deemedappropriate by management.

Minimum FTE Years of Experience

  • Minimum of 3 years’ experience in IRT Project Management

  • Able to read and interpret clinical trial protocols

  • Effective verbal and written communication skills

  • Attention to detail

  • Stakeholder engagement and collaboration experience

  • Cross functional collaboration

  • Ability to adapt in a fast-paced environment

  • Risk Management Experience

  • Familiarity working with Microsoft Project

  • 2 days a week in the Sponsor office required

Educational Requirements

  • B.A. or B.S. degree in Computer Science, Biology, or a related discipline

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Job posted: 2023-06-08

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