Senior Specialist, Clinical Operations Systems
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focusing 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:
As a Clinical Operations Systems Senior Specialist, you will support global systems and tools used by clinical operations teams. You will help with system setup, training, and improving how teams work. A big part of your role will be working with people from different departments and countries to make sure clinical processes are clear, efficient, and consistent. You will also manage data tools, support changes, and share updates across teams. Strong teamwork and communication skills are important, as you will work closely with many internal and external partners to help clinical studies run smoothly, on time, and within budget.
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 new technology deployment and establishing data quality standards/ oversight.
- Support successful execution of training to functional team members on clinical systems and related processes.
- Support identification of new technology needs, technology budget evaluation, and business case development to launch technologies for the Functional Unit.
- Support business requirement specification development for new systems or system enhancements and ensure successful engagement with other cross functional stake holders.
Essential Knowledge & Experience
- Expert knowledge with clinical trial operational data and applications, with preferred administration level support in operational applications
- Knowledge on data flows and data integrations for operational data (i.e.milestones, reference data, or site data), including CRO operations data.
- Experience liaising with stakeholders for specification documents requirements.
- Experienced in measuring and managing data quality metrics and compliance.
Preferred Knowledge & Experience:
- Experience with enterprise system implementation or major enhancement build out.
- Experience as a UAT tester including authoring test scripts or preparing UAT data
- Experience with authoring of aids, process documents, and user training.
- Familiarity with System Lifecycle Management processes and documentation.
- System alignment experience with mappings to enable integrations across different clinical systems such as CTMS, EDC, Payment Solution, IRT.
- Experience with specification or development of user dashboards and reports.
Education:
- University Degree or equivalent
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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