About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
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 work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their caregivers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
As a Site Budget Specialist, you will work within the Site Contract & Budget function, reporting to the Site Contract & Budget Lead and work closely with members of the Site Contract & Budget function, including Site Payment, Ethics & Compliance, and the Clinical Study Teams.
This position will be responsible for the development, delivery and negotiation of site budgets in line with global standards and regional requirements. The Scope may include local and regional countries. This position is based in the UK.
Hybrid Working:
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines
Key Activities for this Role:
- Responsible for the coordination of work within the Site Contract & Budget support function in support of both early and late-stage Clinical Operations.
- Support budget negotiations with clinical investigator sites globally, including appropriate review of escalated budget topics and the implementation of global budget rate cards when applicable.
- Responsible for the support of global best practices as it relates to applying the relevant requirements 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/Ethics & Compliance Organizations.
- Support 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.
- Responsible for the drafting of the Budget Development Workbook based on review of a study protocol and export of information from GrantPlan.
- Utilize the Agiloft Contract system within Astellas including implementation of a streamlined global process.
- Responsible for the interaction and coordination of cross- functional and cross regional strategies to ensure operational alignment within Medical and Development, along with functions outside of M&D including Astellas Legal, Data Privacy, ICF Standards (and others as required) across the early and late-stage clinical organizations (inclusive of MA and RX+ where applicable).
- Work closely with other members of the Site Contract, Budget & Payment team to ensure a streamlined approach across the department, including Site Payments and ICF Lead(s).
Essential Knowledge & Experience:
- Experience in pharmaceutical related drug development or direct equivalent experience handling contractual/transactional legal matters and/or site budget experience.
- Clinical development processes and ICH/GCP knowledge are essential.
- Demonstrate analytical problem solving and decision-making skills, exercise sound judgment and provide practical and constructive feedback.
- Knowledge of ICH/GCP guidelines and regulatory requirements is essential.
- Fluent in English.
- Excellent interpersonal, written and verbal communication skills.
- Administrative skills and computer ability are highly desirable.
- Minimal (5-10%) travel required.
Preferred Experience:
- Experience with site budget.
Education:
- BA/BS degree or equivalent.
Additional Information:
- This is a permanent, full-time position, based in the United Kingdom.
- This position follows our hybrid working model. Role requires a blend of home and minimum once a quarter in office. Flexibility may be required in line with business needs.
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.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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