At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
Are you passionate about clinical systems and digital innovation in clinical trials? 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.
You will be the bridge between clinical operations and technical teams, helping to shape the future of digital tools in clinical development. This is a strategic and hands-on role, ideal for someone with strong system knowledge and a deep understanding of clinical trial processes.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising 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
Astellas’ Global Capability Centres – Overview:
Astellas’ Global Capability Centre’s (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
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.
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