Title:  Clinical Systems Associate, Strategic Business Operations and Execution

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. 

Learn more at Astellas.com.  

Are you driven to make a real difference in the lives of patients?  

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact. 

Astellas’ Global Capability Centres (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 behaviours, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients. 

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 needs. Candidates must be located within a commutable distance of the office. 

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

As a Strategic Business Operations and Execution, Clinical Systems Lead, you will support the systems, processes, and operational activities that help clinical studies run efficiently and compliantly. You will work with clinical teams, vendors, and internal stakeholders to maintain high-quality clinical data, support clinical systems, coordinate contracts and operational activities, and ensure key processes are completed accurately and on time.

This role is ideal for someone who is highly organized, detail-oriented, and interested in clinical operations, clinical systems, and business process support within the pharmaceutical industry.

• Maintain and update clinical operations data, including organization, location, site, investigator, and personnel records.
• Perform data entry, data quality reviews, reconciliations, and corrections across clinical systems.
• Support Clinical Trial Management System (CTMS) activities, including record updates, issue tracking, and user support.  
• Assist with vendor and contract-related processes, including ARIBA requests and invoice reviews.
• Monitor contract status and coordinate follow-up activities with stakeholders.
• Support audits, inspections, compliance activities, and CAPA tracking.
• Help manage training assignments and learning management system activities.
• Maintain SharePoint and intranet pages for the function.
• Contribute to process improvements and operational excellence initiatives.
• Participate in user acceptance testing (UAT), validation activities, and test case execution.
• Support eTMF processes, document management, TMF compliance, and archival activities.
• Create and maintain process documentation, work instructions, job aids, and trackers.

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

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