Sr. Manager, Business System Lead

Takeda; Łódź; On-site; PLN 267,000 - 368,000; Full time

Job summary

Takeda in Lodz, Poland, seeks an experienced Business System Owner for trial delivery systems to drive roadmap prioritization and support the Software Development Lifecycle.

The role partners with R&D DD&T, cross-functional teams, and vendors to define system priorities, manage budgets, and ensure compliance with GxP, 21 CFR 11, and inspection readiness.

Qualifications

• BS/BA required with 5-7 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.

Responsibilities

• 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.

Skills

Stakeholder management

Cross-functional collaboration

Verbal/written communication

Problem-solving

Education

BS/BA

Tools

Veeva EDC

Veeva CTMS

Job description

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Job Description

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 5-7 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

Location

Lodz, Poland

Base Salary Range:

zł 267.400.00 - zł 367,730.00

For information about our benefits, please click here.

Locations

Warsaw, Poland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time