Senior Specialist

🕒 Setembro 15

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

💵 $71.500 - $142.500 / ano

⏰ Tempo Integral

🟠 Sênior

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

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Worldwide Clinical Trials

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

Worldwide Clinical Trials é uma organização global de pesquisa clínica por contrato (CRO) que oferece serviços abrangentes de ensaios clínicos. A empresa é especializada em apoiar estudos em diversas áreas terapêuticas, como oncologia, cardiologia e doenças raras. Com mais de 30 anos de experiência, a Worldwide Clinical Trials enfatiza suporte personalizado e soluções sob medida ao longo de todo o ciclo de vida do desenvolvimento de medicamentos. Seus serviços incluem monitoramento clínico, gestão de dados, recrutamento de pacientes e consultoria regulatória, garantindo precisão e atenção personalizada para cada ensaio clínico.

Descrição

• Develop, review, and assist with negotiation of Site Agreements with institutions and investigators • Provide oversight and expertise for site contract activities throughout clinical trials • Develop investigator grants, Clinical Trial Agreement templates, and applicable plans • Prepare country contract templates • Draft and send Site Agreements and site-related contracts for negotiation • Provide execution timelines and site negotiation status • Coordinate translation of contract materials when applicable • Review study budgets and costs related to contract negotiation • Negotiate contract language and budgets through finalization and execution • Escalate requests outside preapproved parameters, risks, and non-responsive sites • Add equipment information or appendices to Site Agreements when required • Create donation agreements and termination letters as applicable • Review contracts for completeness and accuracy • Finalize contracts and budgets with sites • Perform quality checks before signature processes • Provide contracts and budgets to regulatory teams for submissions when requested • Liaise with legal, data privacy, study teams, sponsors, sites, investigators, and other stakeholders • Facilitate contract signatures • Distribute executed agreements to sites, eTMF, payment teams, sponsors, and internal SharePoint • Maintain real-time tracking tools • Review TMF structure and oversee Investigator Grants Budgets • Act as lead and subject matter expert on site agreements and related processes • Coordinate master budgets, contract plans, and budget plans • Communicate contracting strategies, timelines, and tracking requirements • Develop mitigation plans, resolve negotiation issues, and contribute to process improvement initiatives • Perform other duties as assigned

🎯 Requisitos

• 3 to 5 years of experience as a Contract Specialist in the clinical research, pharmaceutical, or Contract Research Organization industry • Bachelor's degree or equivalent in Business Administration, Finance, Science, or a related field • Excellent verbal and written English language skills • Proficiency with Microsoft Word, Excel, and Outlook • Knowledge and understanding of International Council for Harmonisation (ICH) and Good Clinical Practice (GCP) Guidelines • Knowledge of local country legislation in the sphere of clinical trials and local regulatory requirements • Advanced contract negotiation skills • Proficiency negotiating complex contract terms with clinical sites and vendors • Understanding of international and local clinical trial regulatory requirements, including FDA, EMA, and ICH-GCP • Proficiency in contract management software and tools • Understanding of budgeting and financial principles related to clinical trial contracts • Basic understanding of legal terminology and contract principles • Strong project management, analytical, time management, and problem-solving skills • Ability to manage multiple site contracts, timelines, risks, and deliverables • Ability to work effectively with cross-functional teams • Ability to handle high volumes of work and perform under pressure

🏖️ Benefícios

• Competitive benefits package depending on location • Inclusive and equitable workplace • Transparent compensation • Pay equity and compensation transparency