Contracts and Budgets Negotiator

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Responsibilities:

• Perform negotiation of legal terms and budget terms for Clinical Study Agreements (“CSA”) (i.e., investigator site agreements)
• Perform negotiation of legal terms and budget terms for amendments to CSAs
• Draft and negotiate ancillary site contracts (e.g. PI / Sub-I / department agreements /Study Coordinator) as required
• Utilize Pfizer provided templates. Pfizer requires stand-alone site contracts with the exception of the US, which utilizes master clinical study agreements.
• Produce and maintain site-specific templates where needed to support the Pfizer targeted investigator site list, but limited to the sites within the studies assigned
• Recommend country-specific and site /entity-specific modifications to templates based on site and local regulatory requirements
• Utilize previously negotiated terms for existing contracts between same site/entity and Pfizer
• Perform submission and oversight of site and study specific local language translations. ISS will be required to use Pfizer preferred translation vendors. Pfizer will manage template version control and translations
• ICON’s Legal team may provide support to ISS personnel. For the avoidance of doubt, ISS is not providing legal advice to Pfizer in any capacity.
• Follow Pfizer’s legal guidance document and comments and fallbacks
• Identify contractual and compliance risks for CSA contracting and raise to Pfizer
• Collect information from investigator site to complete Foreign Corrupt Practices Act (FCPA) form and submit to Pfizer
• Prioritize to meet study timelines to minimize impact to planned Site Initiation Visit (SIV) dates.
• Act independent of CRO managing the study
• Perform quality control checks of contracts and amendments prior to upload to DocuSign for electronic signatures
• If electronic signatures are not permissible, provide management of hard copy/ local signature process
• Ensure signatory to CSA is authorized to sign on behalf of the part
• Ensure signatory to the CSA will either be responsible for the contractual obligations or  operating under a Power of Attorney binding a Pfizer entity to the obligations. Pfizer preference is to have Pfizer or Pfizer Affiliates as the contracting entity for CSAs where possibld
• Ensure country-specific signatory requirements are met (e.g., Some countries require signature by local affiliate (e.g. Italy and Canada))
• Support and provide country level intelligence into the selection of signing party at the country level which must consider payment impact, tax issues (VAT / R&D / WHT), establishment (i.e.corporate presence) and relationship to Sponsor
• Collection and submission of payment support forms, including, but not limited to Payee information forms and required tax forms

• Budget negotiation-specific responsibilities:

Requirements:

• Bachelor’s Degree or international equivalent in business, finance, health sciences or related field
• Read write and speak fluent English; fluent in host country language required.
• 6-12 months' previous experience in negotiation of clinical trial agreements

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What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a requesthere.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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