Specialist, Site Contracts - REMOTE - Argentina or Brazil
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About the role
Who we are We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials , and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What the Specialist, Site Contracts, does at Worldwide The Specialist, Site Contracts, is responsible for the development, preparation, negotiation, and finalization, or assistance in the preparation, negotiation, and finalization, of Site Agreements, amendments, and any other documents associated with sponsors and clinical research sites. What you will do 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. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. What you bring to the role Contract Negotiation: Proficient in negotiating contract terms with clinical sites and vendors Ability to identify and address contract issues and disputes efficiently Regulatory Compliance: Good understanding of international and local regulatory requirements for clinical trials (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), International Council for Harmonization - Good Clinical Practice (ICH-GCP)) Ensure all contracts comply with the latest regulations and guidelines Communication: Excellent verbal and written communication skills for effective interaction with internal stakeholders and clinical sites Ability to clearly explain contract terms and processes Strong analytical skills to review and interpret contract terms and financial data Ability to identify risks and develop mitigation strategies Collaboration and Teamwork: Ability to work effectively with cross-functional teams, including legal, finance, and clinical operations Strong project management skills to handle multiple site contracts simultaneously Ability to prioritize tasks, manage timelines, and ensure contract deliverables are met Technical Proficiency: Proficiency in contract management software and tools Strong problem-solving skills to address and resolve contract-related issues Ability to think critically and strategically
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