Senior Specialist

🕒 September 15

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $71.5k - $142.5k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 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.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

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