Clinical Systems Associate, Strategic Business Operations and Execution

Astellas Pharma; Warszawa; Hybrid; PLN 180,000 - 260,000; Full time

Benefits offered by this job

Hybrid work model

Global collaboration

Job summary

Astellas Global Capability Centre in Warsaw, Poland, offers a permanent, hybrid role within our Clinical Operations and Systems team. The position focuses on strategic business operations and clinical systems support to ensure efficient and compliant clinical studies.

The role requires strong data management, CTMS experience, and collaboration across internal teams and external partners. We value detail orientation and English fluency to operate in a global environment.

Qualifications

• Experience gained in a pharmaceutical, biotech, CRO, or clinical research environment.
• Experience using CTMS or other clinical operations applications (ideally Veeva).
• Experience maintaining operational/master/reference data in regulated environments.
• Strong attention to detail with ability to review, validate, reconcile, and correct data.
• Fluent written and spoken English.
• Ability to collaborate with internal teams, vendors, and external partners.

Responsibilities

• Maintain and update clinical operations data (organization, location, site, investigator, personnel).
• Perform data entry, data quality reviews, reconciliations, and corrections across clinical systems.
• Support CTMS activities including record updates, issue tracking, and user support.
• Assist with vendor and contract processes, including ARIBA requests and invoice reviews.
• Monitor contract status and coordinate follow-up with stakeholders.
• Support audits, inspections, compliance activities, and CAPA tracking.

Skills

Fluent English

Attention to detail

Data management

Collaborative teamwork

Education

University degree

Tools

CTMS (Veeva)

Job description

About Astellas

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.

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 – Overview

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.

Working Environment and Location

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.

Purpose and Scope

• 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.

Role and Responsibilities

• 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.

Essential Qualifications

• Initial experience gained in a pharmaceutical company, biotech company, CRO, or clinical research environment.
• Experience using Clinical Trial Management Systems (CTMS) or other clinical operations applications. Ideally Veeva Clinical.
• Experience maintaining operational, master, reference, or directory data within a structured or regulated environment.
• Strong attention to detail with the ability to review, validate, reconcile, and correct data accurately.
• Fluent written and spoken English.
• Ability to work effectively with internal teams, vendors, and external business partners.
• University degree or equivalent qualification.

Preferred Qualifications

• Understanding of clinical trial operations, study lifecycle activities, and site management processes.
• Experience supporting data quality metrics, issue management, and compliance-related activities.
• Experience providing first-line support to system users and coordinating issue resolution.
• Experience with user acceptance testing (UAT), change control, release support, or process documentation.
• Ability to collaborate with clinical operations, data governance, business process, and information systems teams.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like‑minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real‑world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organisational Values and Behaviours

• Accountability
• Courage
• Impact
• Innovation
• Integrity
• One Astellas
• Outcome Focus
• Sense of Urgency

Benefits

Careers | Astellas

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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