Senior Manager, GDO Analytics & Insights

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Takeda is looking for a Senior Manager GDO Analytics & Insights

Objective / Purpose:

• Partners with Data Digital & Technology partners to drive roadmap prioritization and delivery for successful operationalization of trial delivery systems (process listings systems).

• Serves as Business System Owner (BSO) for systems used in trial delivery (process listing systems) and system lead for systems used in trial delivery.

• Accountable for functional/business ownership of trial support systems assigned to as BSO.

Accountabilities:

• Develops and maintains functional (GDO) and cross-functional (R&D Enterprise) stakeholder relationships for an understanding of key challenges and business priorities for assigned systems
• Interprets functional priorities and partners with R&D DD&T and Trial Delivery leadership in the development and execution of system roadmap.
• Collaborates with R&D DD&T (digital data technology) colleagues and product teams for operational decisions and technical discussions associated with successful roadmap delivery.
• Serves as BSO (Business System Owner) for trial delivery systems to support Software Development Lifecycle.
• Contributes to inspection readiness of trial deliver systems and representation of system expertise for inspection-facing activities including anticipation of internal/external needs.
• Supports the Sr. Director Trial Delivery Systems Strategy in cross-functional efforts to build out processes and infrastructure necessary to support Takeda ways of working.
• Stays informed on vendor and innovation landscape for trial delivery systems.
• Contributes to annual budget planning forecasting and budget management for trial delivery systems; oversight of system investment budget for build and run/support activities.
• Supports value realization for system investments across trial delivery systems.
• Serves as the Subject Matter Expert (SME) and internal consultant to management for assigned system and provides consultative expertise to GDO.

Education & Competencies (Technical and Behavioral):

• BS/BA required with 9 years of relevant experience in the life sciences drug development trial delivery technology implementation product management or strategic roadmap definition.
• Experience with Veeva EDC or Veeva Clinical eTMF/CTMS highly preferred
• Experience with process or process owner network systems highly preferred
• Experience with software implementation within biopharma organizations highly preferred
• Experience with GCP inspection settings with an understanding of system compliance requirements including GxP validation and 21 CFR part 11 requirements requirements around blinded data experience supporting system regulatory inspections.
• Experience with budget management financial planning and forecasting
• Track record of cross-functional collaboration in a matrixed environment

• Strong verbal/written communication skills and ability to influence at all levels across functions and build effective relationships

• Strong interpersonal and problem-solving skills.