Sr. Manager, Trial Support Systems - (Warsaw, Mazovia, Poland)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Objective / Purpose: - Partners with Data, Digital & Technology partners to drive roadmap prioritization and delivery for successful operationalization of trial support systems (process, listings systems). - Serves as Business System Owner (BSO) for systems used in trial support (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 expertis 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 Warsaw, Poland Base Salary Range: zł 267.400.00 - zł 367,730.00   For information about our benefits, please click here. LocationsWarsaw, Poland Worker TypeEmployee Worker Sub-TypeFixed Term (Fixed Term) Time TypeFull time