Site Contract & Budget Manager
About Astellas:
At Astellas we are making treatments that matter to people.
We are tackling the toughest health challenges putting the patient at the heart of every move we make.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
The Opportunity:
As a Site Contract & Budget Manager, you will be responsible for the development, delivery and negotiation of site contracts and / or budgets in line with global standards and regional requirements, the scope may include local and regional countries.
This position will work within the Site Contract & Budget function reporting to the Regional Site Contract & Budget Lead and work closely with members of the Site Contract & Budget function including Site Payment, Legal, and Data Privacy. This position is based in Milan, Italy.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life. This role offers a remote working solution so you can optimise the most productive work environment for you to succeed and deliver.
Key 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 timeline and 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.
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.
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