Clinical Operations Systems Lead – Astellas Pharma

Join our Strategic Business Operations and Execution (SBOE) team as a Clinical Operations Systems Lead. In this role, you will drive the implementation and optimization of clinical technologies, ensuring high data quality and smooth system operations across global clinical studies.

Hybrid Working

Astellas offers a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home, optimizing the most productive work environment for you to succeed and deliver.

Key Responsibilities

• Support system integration across platforms (e.g., CTMS, EDC, IRT, Payments).
• Support deployment of new clinical technologies and ensure data quality oversight.
• Support training initiatives for clinical teams on systems and processes.
• Identify technology needs and contribute to business cases and budget planning.
• Develop business specifications for new systems and collaborate with cross-functional teams.
• Oversee operational standards and process efficiency across clinical systems.
• Contribute to documentation such as UAT scripts, job aids, and process guides.
• Collaborate with records management and regulatory teams for compliance.

Essential Knowledge & Experience

• Strong knowledge of clinical trial operational data and systems (e.g., CTMS, EDC).
• Experience as a UAT tester and familiarity with test script creation.
• Understanding of CRO data integrations (milestones, site data, reference data).
• Experience with system alignment and integration mapping across platforms.
• Ability to support business requirements documentation and process design.
• Hands‑on experience with operational system administration.

Preferred Knowledge & Experience

• Experience with enterprise system implementation or major enhancements.
• Experience with authoring job aids and process documents.
• Knowledge of System Lifecycle Management and related documentation.
• Experience with data governance and dashboard/report specifications.
• Background in portfolio or project management systems.
• Ability to measure and manage data quality metrics and compliance.

Education/Qualification

• University degree in a related field.

Additional Information

This is a permanent role based in our Global Capability Centre in Warsaw, Poland and hybrid working with the expectation for some office presence. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.