IRT Operations Manager

Компания: Biogen
Вид работа: Пълен работен ден

Job Description
The Global Clinical Supply Chain group is looking to expand and hire an Operations Manager to serve as the SME and operations lead in the IRT space. This person will be managing the day-to-day performance of Biogen’s IRT system vendors and the outsourced operations. In addition, this role will directly own and operate individual trial management systems. The role also includes leading quality management for IRT including issue resolution and continuous improvement, defining and implement IRT and vendor metrics that will drive team performance and provide actionable insight for PO&T and R&D, as well as acting as Business Process Owner (BPO).
This is a hybrid role that will be based at our headquarters in Cambridge, MA.
What You’ll Do
IRT System and Process Owner: Day-to-day operational management of IRT (IXRS, RTSM) system providers including integrations from acquisitions.
Collaborates with key process partners in the sourcing, evaluation as well as audit/qualification of IRT systems
Partners with IRT Lead on defining IRT vendor strategy and conducting quarterly Business Review Meetings.
Owns process and procedure management for IRT, as well as training curriculum and execution. Collaborates with internal and external functions to ensure Biogen practices and processes are being adhered to.
Owns and executes all Quality and documentation workflows related to IRT within Biogen systems.
IRT Senior ContributorMaintains admin level access and working knowledge for all Biogen IRT systems to remain up to date with system performance across standards and vendor platforms.
Manages system lifecycle and maintains Biogen IRT standards and their adoption.
IRT Metrics LeadsDefines, implements and maintains IRT operations metrics that provide actionable insights for IRT and broader GCSC management.
Analyzes and improves supplier metrics to assess relationship health and highlight quality risks.
IRT FSP Outsourced Servies EngagementDay-to-day operational management of the outsourced service including task prioritization, team performance and issue resolution.
Partners with IRT Lead on outsourced service budgeting, accounting and resource planning and quarterly business reviews.
CI Initiatives Leadership Leads continuous improvement activities to create additional value from IRT.
Maintains connection to IRT industry and brings in industry best practice opportunities.

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