
1001 - 5000 employees
đĽ Healthcare
đź Consulting
đŚ Logistics
Healthcare ⢠Consulting ⢠Logistics
Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.
đĽ 14 hours ago
đ Argentina, Brazil â Remote
â° Full Time
đ˘ Junior
⨠Contracts Specialist
đť Ghost score 10%
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1001 - 5000 employees
đĽ Healthcare
đź Consulting
đŚ Logistics
Healthcare ⢠Consulting ⢠Logistics
Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.
⢠Prepare country contract templates ⢠Draft and send Site Agreements and site-related contracts to begin negotiations ⢠Provide planned execution timelines and negotiation status ⢠Send items for translation and receive or translate items when applicable ⢠Review study budgets and costs related to contract negotiation ⢠Negotiate contract language and budgets with assigned sites through finalization and execution ⢠Escalate site requests outside preapproved parameters to the Site Contracts Lead and Sponsor ⢠Escalate risks and non-responsive sites to the Site Contracts Lead or internal team ⢠Add appropriate information or appendices to Site Agreements when equipment is provided ⢠Create donation agreements when applicable ⢠Review Site Agreements and associated contracts for completeness and accuracy ⢠Finalize contracts and budgets with sites ⢠Perform quality checks before the signature process ⢠Provide contracts and budgets to the regulatory team for submissions when requested ⢠Liaise with Legal, Data Privacy, study teams, Sponsors, sites, investigators, and other stakeholders ⢠Facilitate contract signatures ⢠Distribute fully executed agreements to sites, eTMF, payment team, Sponsor, and internal SharePoint ⢠Negotiate Site Agreement amendments and budgets ⢠Create termination letters and related documents ⢠Maintain tracking tools with live, real-time, or regular updates ⢠Prioritize effectively and respond to urgent requests ⢠Perform other duties as assigned
⢠Bachelorâs degree or equivalent in business administration, finance, science, or a related field ⢠1 to 3 years of experience in the Contract Research Organization, pharmaceutical, or clinical research 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 International Council for Harmonization (ICH) and Good Clinical Practice (GCP) guidelines ⢠Knowledge of local country legislation and regulatory requirements related to clinical trials ⢠Proficiency in negotiating contract terms with clinical sites and vendors ⢠Ability to identify and address contract issues and disputes efficiently ⢠Understanding of international and local regulatory requirements for clinical trials, including FDA, EMA, and ICH-GCP ⢠Strong analytical, communication, project management, problem-solving, time management, and organizational skills ⢠Proficiency in contract management software and tools ⢠Understanding of budgeting and financial principles related to clinical trial contracts ⢠Basic understanding of legal terminology and principles related to contracts ⢠Ability to work effectively with cross-functional teams, including legal, finance, and clinical operations ⢠Ability to handle high volumes of work and work under pressure
⢠Equal employment opportunities ⢠Diverse and inclusive work environment ⢠Supportive and collaborative teams ⢠Accessible leadership ⢠Employee opportunities to succeed and develop professionally
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