Site Contract

Job description:

Purpose and Scope

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. The position 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.

Role and Responsibilities

• This position is responsible for the coordination of work within the Site Contract & Budget support function in support of both early and late-stage Clinical Operations.
• Support of 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
• Support of budget negotiations with clinical investigator sites globally, including appropriate review of escalated budget topics and the implementation of global budget rate cards when applicable
• This position is responsible for the support of 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.
• This position supports 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.
• This position is will utilize the Agiloft Contract system within Astellas including implementation of a streamlined global process
• This position may have responsibility 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).
• This position will need to 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)

Required Qualifications

• BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience handling contractual / transactional legal matters and / or site budget experience.
• Experience of the 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.
• Demonstrate analytical problem solving and decision-making skills, exercise sound judgment and provide practical and constructive feedback.
• Strong communication skills (both oral and written).
• Must have knowledge of clinical development processes and ICH/GCP
• Must have knowledge of ICH/GCP guidelines and regulatory requirements
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Fluent in English.
• Minimal (5-10%) travel required

Prefered Qualifications

• Experience with both site contract and budget

Location

• This position is based in São Paulo and will require on-site work.
• 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.