Job Posting
Sr. Manager, Trial Support Systems
Lodz, Łódź Voivodeship Job ID R0184178 Category Data, Digital and Technology Subcategory Data, Digital and Technology,Data, Digital and Technology Business Unit Research & Development Job Type Full timeBy 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, PolandBase Salary Range:
zł208,000.00 - zł286,000.00For information about our benefits, please click here.
