Sr. Manager, Business System Lead

POL - 6999 Takeda SCE; Warszawa; On-site; PLN 267,000 - 368,000; Full time

Job summary

Takeda is seeking a seasoned Business System Owner for trial delivery systems in Poland (Lodz/Warsaw). You will partner with Data, Digital & Technology to prioritize roadmaps and ensure delivery in line with GxP and 21 CFR Part 11 requirements, supporting the SDLC and regulatory inspections.

The role requires a BS/BA with 5-7 years in life sciences or drug development, experience with Veeva EDC/CTMS, budget planning, and strong cross-functional collaboration and communication.

Qualifications

• BS/BA required with 5-7 years of relevant experience in the life sciences or drug development.
• Experience with Veeva EDC or Veeva Clinical eTMF/CTMS highly preferred.
• Experience with GxP validation and 21 CFR Part 11 requirements is important.
• Experience with budget management, forecasting and cross-functional collaboration.
• Strong verbal and written communication and influencing across levels.

Responsibilities

• Partner with Data, Digital & Technology to drive roadmap delivery for trial systems.
• Serve as Business System Owner for trial delivery systems and support the SDLC.
• Develop and maintain cross-functional stakeholder relationships across R&D and Enterprise.
• Contribute to inspection readiness and represent system expertise for inspections.
• Support budget planning and investment oversight for trial delivery systems.

Skills

Veeva EDC

Veeva eTMF/CTMS

Cross-functional collaboration

Budget management

Regulatory inspections

Communication skills

Education

BS/BA in life sciences or related

Job description

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.

Locations

• Lodz, Poland
• Warsaw, Poland

Base Salary Range

zł 267.400.00 - zł 367,730.00

Employment Type

Employee Worker Sub-Type Regular Time Type Full time

About the Company

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.

Equal Employment Opportunity

Takeda is an equal opportunity employer.