Algemene informatie
Vacatureadvertentie
Site Contract \& Budget Manager
Locatie
Italië
Functie/Business Area
Research
Werkcategorie
Arbeidsovereenkomst voor onbepaalde tijd
Functiebeschrijving
Site Contract \& Budget Manager
About Astellas
At Astellas, experience is coupled energised with a relentless challenger spirit.
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 are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation.
We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers.
We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients.
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 Italy.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising 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 elements.
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.
Preferred Experience:
Experience with both site contracts and budgets.
Experience in working cross-functionally and with external providers.
Education/Qualifications:
BA/BS degree in life science or equivalent.
Additional Information:
This is a permanent, full-time position.
Minimal (5-10%) travel required.
This position is based in 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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