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Job Description
Takeda is looking for a Senior Manager, GDO Analytics & Insights
Objective / Purpose:
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Partners with Data, Digital & Technology partners to drive roadmap prioritization and delivery for successful operationalization of trial delivery systems (process, listings systems).
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Serves as Business System Owner (BSO) for systems used in trial delivery (process listing systems) and system lead for systems used in trial delivery.
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Accountable for functional/business ownership of trial support systems assigned to as BSO.
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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): _
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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.
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Experience with Veeva EDC or Veeva Clinical eTMF/CTMS highly preferred
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Experience with process or process owner network systems highly preferred
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Experience with software implementation within biopharma organizations highly preferred
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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.
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Experience with budget management, financial planning and forecasting
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Track record of cross-functional collaboration in a matrixed environment
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Strong verbal/written communication skills and ability to influence at all levels across functions and build effective relationships
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Strong interpersonal and problem-solving skills.
Locations
IND - Bengaluru
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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