Study Contracts Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $112.2k - $168.2k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 0%

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AstraZeneca

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🧬 Biotechnology

🏥 Healthcare

Pharmaceuticals • Biotechnology • Healthcare

AstraZeneca is a global biopharmaceutical company focused on discovering, developing and manufacturing prescription medicines. The company emphasizes scientific research and innovation, with large-scale R&D and global business operations aimed at transforming healthcare for people, society and the planet.

📋 Description

• Adapt global agreement templates for local use in accordance with local requirements and SOPs • Develop and negotiate clinical site budgets based on Fair Market Value • Negotiate agreement language and budgets with clinical study sites • Interface with Legal to ensure contract integrity • Maintain agreement, budget, issue, payment, amendment, and communication status throughout studies • Ensure final contract documents reflect negotiated agreements • Ensure timely execution of agreements to support efficient site start-up • Support internal and external audits • Ensure compliance with AstraZeneca’s Code of Conduct and company policies • Ensure all contracts are included in the Trial Master File (TMF) • Train and mentor new local Study Team members on financial and contractual issues • Support preparation and negotiation of Local Master Service Agreements • Contribute to process improvements, knowledge transfer, and best-practice sharing

🎯 Requirements

• Bachelor’s degree in a related discipline required • 4+ years of experience negotiating industry contracts such as Clinical Study Agreements, CDAs, and amendments for sites, SMOs, CROs, or Sponsors • Experience developing clinical trial budgets from study protocols, including Fair Market Value assessments • Ability to support multiple studies and agreement types • Experience negotiating CSAs, CDAs, amendments, and creating budgets • Excellent knowledge of international ICH-GCP guidelines • Basic knowledge of GMP/GDP • Good knowledge of relevant local regulations • Basic understanding of the drug development process • Good understanding of Clinical Study Management, including monitoring, study drug handling, and data management • Excellent attention to detail • Good written and verbal communication skills • Good collaboration and interpersonal skills • Good negotiation skills

🏖️ Benefits

• Short-term incentive bonuses • Equity-based awards for salaried roles • Qualified retirement programs • Paid time off, including vacation, holidays, and leaves • Health coverage • Dental coverage • Vision coverage • Flexible benefits offering • Personal development opportunities • Inclusive and equitable work environment