Site Contracts Specialist

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Prepare templates for country contracts.

• Draft and distribute Site Agreements or any contracts related to sites to initiate negotiations.

• Provide timelines for site contract execution and update on site negotiation status.

• Send items for translation when necessary, and manage the receipt and translation of returned documents.

• Review study budgets and costs associated with contract negotiations.

• Negotiate contract terms and budgets with each designated site until finalization and execution.

• Escalate site requests that fall outside pre-approved parameters to the Site Contracts Lead for Sponsor review.

• Report risks and non-responsive sites to the Site Contracts Lead or the internal team, as needed.

• Ensure that relevant information or appendices are included in Site Agreements or related documents when equipment is supplied to sites.

• Develop donation agreements as necessary.

• Review Site Agreements and related contracts for thoroughness and accuracy.

• Finalize contracts and budgets with sites.

• Conduct quality checks of Site Agreements and related documents prior to the signature process.

• Provide draft or signed contracts and budgets to the regulatory team for submission purposes upon request.

• Collaborate with the Worldwide Clinical Trials Legal Department, Data Privacy team, study teams, Sponsors, sites, and investigators.

• Facilitate contract signatures by Worldwide Clinical Trials as 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 amendments to Site Agreement language and budgets with sites.

• Create termination letters or other related documents and send them to sites for signature, as applicable.

• Maintain tracking tools with live, real-time updates for functional activities.

• Prioritize tasks effectively and respond to urgent requests from the internal team or the Sponsor.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor's degree or equivalent in Business Administration, Finance, Science, or a related discipline.

• 1 to 3 years of experience in the pharmaceutical or Contract Research Organization (CRO) sector, working with investigator/site contracts or a related legal field.

• Exceptional verbal and written communication skills in English.

• Proficiency in Microsoft Word, Excel, and Outlook.

• Understanding of ICH-GCP Guidelines, along with local country legislation and regulatory requirements pertaining to clinical trials.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Paid time off.

• Flexible work arrangements.

• Professional development.