Site Contract & Budget Manager

Overview

Site Contract & Budget Manager – Astellas Pharma. This role is based in Milan, Italy, with a hybrid working model offering remote work and a requirement to be within a commutable distance to the office as needed.

Responsibilities

• Managing the coordination of work within the Site Contract & Budget support function in support of both early and late-stage Clinical Operations.
• Supporting negotiations with clinical investigator sites and others as needed to facilitate master clinical trial agreements/clinical trial agreements ensuring that contract language provided to clinical investigator sites aligns with the expectations of established Astellas legal positions.
• Providing budget negotiations with clinical investigator sites globally, including appropriate review of escalated budget topics and the implementation of global budget rate cards when applicable.
• Implementing global best practices as it relates to applying the relevant legal requirements and global data privacy matters in the support of clinical trial execution/oversight that adhere to Astellas and GCP/ICH requirements and are developed in close collaboration with Astellas Legal/Data Privacy Organizations.
• Ensuring the efficient delivery of site/investigator clinical contracts and/or budgets, aligned with informed consent language and other general legal language guidelines for clinical site documents that ensure compliance, regional, operational and legal standards, while ensuring contracts and/or budgets are delivered in a timely quality manner to meet study/project timelines.

Essential Knowledge & Experience

• Solid experience in pharmaceutical related drug development or direct equivalent experience handling contractual/transactional legal matters and/or site budget experience.
• Proven experience in legal and data privacy issues affecting the pharmaceutical industry, including GDPR, regulatory processes for prescription drugs, anti-kickback, fraud and abuse, anti-bribery and anti-corruption and antitrust laws, IP, manufacturing, R&D, regulatory and commercial element.
• Demonstrable analytical problem solving and decision-making skills, exercise sound judgment and provide 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.

Education

• BA/BS degree life science or equivalent.

Preferred Experience

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

Additional Information

• This is a permanent full-time position.
• Minimal (5-10%) travel required.
• This position is based in Milan, Italy.
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

Equal Opportunity

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.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Finance and Sales

Industries

• Pharmaceutical Manufacturing