Sr. Manager, Trial Support Systems

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 Locations Lodz, Poland Base Salary Range: zł208,000.00 - zł286,000.00 For information about our benefits, please click here. Worker Type Employee Worker Sub-Type Regular Time Type Full time Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer. For applicants of U.S and Puerto Rico positions: Click here to learn about our commitment to Equal Employment Opportunity (EEO). If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability please click here.