
10,000+ employees
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
Healthcare • Biotechnology • Pharmaceuticals
Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.
🔥 4 minutes ago
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10,000+ employees
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
Healthcare • Biotechnology • Pharmaceuticals
Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.
• Prepare country site budgets and study financial appendices • Assist with negotiation of site agreement budgets and financial exhibits of a certain complexity • Develop Clinical Trial Agreements (CTAs) using standard templates and Contract Information Sheets • Ensure CTAs are executed timely to meet study start-up timelines • Liaise with legal departments regarding CTA content changes and approved agreement language • Participate in study kick-off meetings • Review proposed CTA language modifications and resolve compliance issues with legal, sites, contractors, or vendors • Generate site budgets from approved country budgets and follow up with investigators • Research medical procedure costs using local or global databases • Manage CTAs and update agreement components according to client legal standards and Global SOPs • Coordinate annual template reviews with Legal and Local Head of Monitoring and Site Management • Manage the contract tracking database and reconcile document/database discrepancies • Post fully executed contracts in eFiliA and on the Clinical Operations secure drive • Process internal approval forms and other documents for compliance and annual audits • Serve as point person among clinical trial site personnel, client Clinical Operations, Legal Counsel, and Manager, Insurance • Prepare for internal audits by maintaining complete and accurate negotiation records • Negotiate Master Services Agreements (MSAs) with institutions and ensure review before renewal dates
• Must have a Bachelors’ degree or an equivalent scientific or commercial Higher Vocational education • Experience in the healthcare field, pharmaceutical industry or clinical research preferred • Solid understanding of standard contract language • Ability to access and use a variety of computer software developed both in-house and off-the-shelf • Ability to sit for extended periods and operate a vehicle safely • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck • Light to moderate lifting and carrying objects including luggage and laptop computer with a maximum lift of 15-20 lbs. • Regular and consistent attendance • Varied hours may be required • Frequent travel to clients/site locations with occasional domestic and international travel
• Medical insurance • Dental insurance • Vision insurance • Life insurance • Short-term disability (STD) • Long-term disability (LTD) • 401(K) • Employee Stock Purchase Plan (ESPP) • Paid time off (PTO) or Flexible time off (FTO) • Company bonus where applicable
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🇺🇸 United States – Remote
💵 $65k - $85k / year
💰 Private equity on 2023-03
⏰ Full Time
🟡 Mid-level
🟠 Senior