IRT Tech Project Manager-Remote

The IRT Tech Project Manager is Responsible for providing subject matter expert (SME) support and consultation for the entire System Development Lifecyle (SDLC) of the IRT system for assigned pharmaceutical sponsor. The job includes but not limited to support in the development of the Request for Proposal (RFP), IRT Kick-Off Meeting, User Requirement Specification (URS), IRT functional and best practices sponsor standards, vendor management, User Acceptance Testing (UAT), and support in sponsor initiatives.

What to Expect

• Collaborate with sponsor stakeholders to ensure the IRT meets study protocol needs

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  Ensure IRT best practices are used to meet the need of the clinical and supply teams

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  Lead clinical and supply teams in IRT problem identification and problem solution. Help drive an understanding of the root cause; ensure corrective and preventative actions are recorded and address the root cause. If applicable, ensure effectiveness checks are installed and address the issue root cause

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  Escalate system issues or problems within the appropriate IRT vendor and/or sponsor communication pathways

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  Actively participate in vendor management meetings to engage IRT vendors to help create a collaborative relationship

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  As directed by sponsor, lead/support UAT activities

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  Understand the various integrations that can interface with the IRT. Help identify and address issues between IRT and integrated vendor

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  Help educate and drive best practices with sponsor stakeholders

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  100% Remote

Education/Qualifications

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  University / college degree (life sciences, health sciences, information technology or related subjects preferred).

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  Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree.

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  Fluent in English, both written and verbal
  

Experience

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  Proven ability in understanding the IRT SDLC

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  High-level understanding of clinical supply and clinical operations within pharmaceuticals

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  Knowledge of databases and various tools used to help extract and disseminate study information

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  Working experience with statistical and clinical operations interaction

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  Ability to clearly communicate and report on IRT data to help teams understand issue, trend, or IRT/protocol need

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  Working understanding of GCP and GMP regulations

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  Proficient with Microsoft tools (Word, Excel, Visio, PowerPoint, Project, Teams)

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