Clinical Contracts Negotiator at ICON plc

Job Functions/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 Sponsor´s provided templates. Sponsor´s 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 Sponsor´s 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 Sponsor´s
• Perform submission and oversight of site and study specific local language translations. Candidate will be required to use Sponsor´s preferred translation vendors. Sponsor´s will manage template version control and translations
• Attend weekly study team and country meetings, as needed
• Identifies risk and mitigation strategies as it relates to meeting contract negotiation timelines
• ICON’s Legal team may provide support to ISS personnel. For the avoidance of doubt, ISS is not providing legal advice to Sponsor´s in any capacity.
• Follow Sponsor´s’s legal guidance document and comments and fallbacks
• Identify contractual and compliance risks for CSA contracting and raise to Sponsor´s
• Collect information from investigator site to complete Foreign Corrupt Practices Act (FCPA) form and submit to Sponsor´s
• 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
• Contractual Parties:
• Ensure signatory to CSA is authorized to sign on behalf of the party
• Ensure signatory to the CSA will either be responsible for the contractual obligations or operating under a Power of Attorney binding a Sponsor´s entity to the obligations. Sponsor´s preerence is to have Sponsor´s or Sponsor´s Affiliates as the contracting entity for CSAs where possible
• Ensure country - specific singnatory 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 part 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 requirements:
• Pre-populate site-specific budget items from prior negotiations following Sponsor´s provided guidelines.
• Negotiate site budgets following Sponsor’s principles document and comments & fallbacks
• Actively participate in per-subject cost development meeting. ISS personnel will provide review and input into the country specific budget templates to minimize timelines for site budget negotiations.
• Provide country level expertise to budget related contract terms and conditions
• Escalate out of parameter budget items to Sponsor´s Investigator Contracts Lead (ICL)
• Record negotiated changes to patient compensation information and provide to Sponsor´s designated contact for Informed Consent Document (ICD)
• Demonstrate effective time management skills; able to independently prioritize multiple tasks.
• Demonstrate the ability to work independently and use initiative to anticipate/resolve issues and complete tasks.
• Shows a commitment to and demonstrate the ability to consistently perform high quality work with minimal management oversight.

Education 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.
• 2 years Industry experience managing and negotiating contracts in South Africa, Israel and Nordics highly preferred.