Clinical Systems Lead, Hybrid (Operations & Data)

Biopharma Careers; Warszawa; Hybrid; PLN 150,000 - 190,000; Full time

Job summary

Astellas is seeking a Strategic Business Operations and Execution, Clinical Systems Lead to support systems, processes, and operational activities for clinical studies. The role is based in Warsaw, Poland, with hybrid work and some office presence to collaborate with clinical teams, vendors, and internal stakeholders.

You will maintain high-quality clinical data, coordinate contracts, and ensure key processes are completed accurately and on time.

Qualifications

• Experience using Clinical Trial Management Systems (CTMS) or other clinical operations applications.
• Fluent written and spoken English.
• University degree or equivalent qualification.
• Ability to work effectively with internal teams, vendors, and external business partners.

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.

Skills

Data quality

Attention to detail

Stakeholder collaboration

English fluency

Education

University degree or equivalent

Tools

CTMS (Veeva)

SharePoint

Job description

Astellas is seeking a Strategic Business Operations and Execution, Clinical Systems Lead to support systems, processes, and operational activities for clinical studies. The role is based in Warsaw, Poland, with hybrid work and some office presence to collaborate with clinical teams, vendors, and internal stakeholders.

You will maintain high-quality clinical data, coordinate contracts, and ensure key processes are completed accurately and on time.