Sr. Manager, Trial Support Systems

Takeda; Łódź; On-site; PLN 208,000 - 286,000; Full time

Job summary

Takeda in Lodz, Poland, seeks a Business System Owner for trial delivery systems to drive roadmaps and operationalize trial support platforms.

Role requires collaboration across R&D, DD&T, and Trial Delivery, with focus on GxP compliance, inspections, and budget oversight for system investments.

Qualifications

• BS/BA required with 5-7 years in life sciences, drug development, or roadmap definition.
• Experience with Veeva EDC or Veeva Clinical eTMF/CTMS highly preferred.
• Experience with software implementation in biopharma environments preferred.

Responsibilities

• Develops and maintains stakeholder relationships across GDO, R&D DD&T, and Trial Delivery to understand business priorities for assigned systems.
• Interprets functional priorities and partners with R&D DD&T and Trial Delivery leadership to develop and execute system roadmaps.
• Collaborates with R&D DD&T colleagues and product teams for operational decisions related to roadmap delivery.
• Serves as BSO for trial delivery systems to support Software Development Lifecycle.
• Contributes to inspection readiness and represents system expertise for inspection-facing activities.

Skills

Cross-functional collaboration

Stakeholder management

Regulatory knowledge

Systems thinking

Education

BS/BA in Life Sciences

Tools

Veeva EDC

Veeva CTMS/eTMF

GxP validation

Job description

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

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time