Overview

Site Contract & Budget Manager at Astellas is responsible for the development, delivery, and negotiation of site contracts and/or budgets in line with global standards and regional requirements. The position is based in Warsaw, Poland and works within the Site Contract & Budget function reporting to the Regional Site Contract & Budget Lead.

Key Activities

• Coordinate work within the Site Contract & Budget support function for early and late‑stage Clinical Operations.
• Support negotiations with clinical investigator sites to facilitate master clinical trial agreements, ensuring contract language aligns with Astellas legal positions.
• Provide budget negotiations with clinical investigator sites globally, reviewing escalated budget topics and implementing global budget rate cards.
• Implement global best practices for legal requirements and data privacy in clinical trial execution, in collaboration with Astellas Legal/Data Privacy organizations.
• Ensure efficient delivery of site/investigator contracts and/or budgets, meeting study/project timelines and quality standards.

Essential Knowledge & Experience

• Solid experience in pharmaceutical drug development or equivalent handling contractual/transactional legal matters and/or site budget experience.
• Proven experience in legal and data privacy issues affecting the pharmaceutical industry, including GDPR, anti‑kickback, fraud and abuse, anti‑bribery and anti‑corruption, antitrust laws, IP, manufacturing, R&D, regulatory and commercial elements.
• Demonstrable analytical problem‑solving and decision‑making skills, exercising sound judgment and providing practical and constructive feedback.
• Proficient in English and the primary language of the country of employment.
• Strong knowledge of clinical development processes and ICH/GCP guidelines and regulatory requirements.

Preferred Qualifications

• Experience with both site contracts and budgets.
• Experience working cross‑functionally and with external providers.

Education

• BA/BS degree in life science or equivalent.

Additional Information

• This is a permanent, full‑time position based in Warsaw, Poland and hybrid working with the expectation for some office presence.

EEO Statement

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.