Study Contracts Manager - Cell Therapy
Hybrid · Sydney, New South Wales, Australia
Job Summary
Study Contracts Manager at AstraZeneca Australia based in Sydney with hybrid work (in the office 3 days/week). You will lead clinical site contracts and budgets, adapt global agreement templates to local requirements, negotiate with investigators and institutions using FMV budgeting, track agreement status and payments, and collaborate with Legal and study teams to safeguard contract integrity. You’ll support audits, contribute to process improvements, mentor colleagues on financial/contractual practices, and help prepare and negotiate a local Master Service Agreement. The role requires a Bachelor’s degree in life science, law, or finance, extensive clinical trial contracting experience (5–7 years), strong knowledge of ICH-GCP and local regulations, familiarity with FMV-based budgeting, and travel as needed. Desirable: post-graduate training in contracts administration or pharma/healthcare paralegal experience; experience in remote collaboration and international studies.
Required Qualifications
- Bachelor’s degree in life science, law, finance, or equivalent qualification
- Extensive clinical trial contracting expertise (5-7 years) with demonstrable negotiation skills and FMV-based budget development
- Strong knowledge of ICH-GCP and relevant local regulations; basic GMP/GDP awareness
- Experience in pharmaceutical (preferred) or CRO environments
- Ability to travel nationally
- Desirable: Post-graduate training in contracts administration or paralegal experience in pharma/healthcare
- Familiarity with risk-based monitoring and good cultural awareness in international studies
- Tech-savvy with ability to use e-enabled systems/software in clinical operations
Desired Qualifications
- Bachelor’s degree in life science, law, finance, or equivalent qualification
- Extensive clinical trial contracting expertise (5-7 years)
- FMV-based budget development
- Strong knowledge of ICH-GCP and relevant local regulations
- Experience in pharmaceutical or CRO environments
- Ability to travel nationally
- Post-graduate training in contracts administration or paralegal experience in pharma/healthcare (Desirable)
- Remote collaboration experience (Desirable)
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