Site Contracts Specialist

Role Overview

• Prepare country contract templates
• Draft and send Site Agreements or any contracts associated with sites to begin negotiations
• Provide site contract execution planned timelines and site negotiation status
• Send items for translation, if applicable, and receive and translate the returned documents
• Review study budgets and costs regarding contract negotiation
• Negotiate contract language and budgets with each assigned site through finalization and execution
• Escalate site requests outside of preapproved parameters to the Site Contracts Lead for Sponsor review
• Escalate risks and non-responsive sites to the Site Contracts Lead or internal team, as applicable
• Ensure appropriate information or appendices are added to Site Agreements or related documents when equipment is provided to sites
• Create donation agreements, as applicable
• Review Site Agreements and associated contracts for completeness and accuracy
• Finalize contracts and budgets with sites
• Perform quality checks of Site Agreements and related documents before the signature process begins
• Provide draft or signed contracts and budgets to the regulatory team for submission purposes, when requested
• Liaise with the Worldwide Clinical Trials Legal Department, Data Privacy team, study teams, Sponsors, sites, and investigators
• Facilitate contract signatures by Worldwide Clinical Trials, when applicable
• Distribute fully executed Site Agreements and related documents to sites, electronic Trial Master File (eTMF), payment team, Sponsor, and internal SharePoint, as applicable
• Negotiate Site Agreement amendment language and budgets with sites
• Create termination letters or other related documents and send to sites for signature, as applicable
• Maintain tracking tools with live, real-time, and regular updates for functional activities
• Prioritize effectively and respond to urgent requests within the internal team or from the Sponsor
• Perform other duties as assigned.

Requirements

• Bachelor's degree or equivalent in Business Administration, Finance, Science, or a related field
• 1 to 3 years of experience in the pharmaceutical or Contract Research Organization (CRO) industry, working with investigator/site contracts or a related legal field
• Excellent verbal and written English language skills
• Proficiency with Microsoft Word, Excel, and Outlook
• Knowledge and understanding of ICH-GCP Guidelines, as well as local country legislation and regulatory requirements related to clinical trials

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements
• Professional development