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
Ensure IRT best practices are used to meet the need of the clinical and supply teams
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
Escalate system issues or problems within the appropriate IRT vendor and/or sponsor communication pathways
Actively participate in vendor management meetings to engage IRT vendors to help create a collaborative relationship
As directed by sponsor, lead/support UAT activities
Understand the various integrations that can interface with the IRT. Help identify and address issues between IRT and integrated vendor
Help educate and drive best practices with sponsor stakeholders
University / college degree (life sciences, health sciences, information technology or related subjects preferred).
Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree.
Fluent in English, both written and verbal
Proven ability in understanding the IRT SDLC
High-level understanding of clinical supply and clinical operations within pharmaceuticals
Knowledge of databases and various tools used to help extract and disseminate study information
Working experience with statistical and clinical operations interaction
Ability to clearly communicate and report on IRT data to help teams understand issue, trend, or IRT/protocol need
Working understanding of GCP and GMP regulations
Proficient with Microsoft tools (Word, Excel, Visio, PowerPoint, Project, Teams)
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