AstraZeneca
SiteStart-up&StudyContractManager
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Site Start-up & Study Contract Manager at AstraZeneca. Skills: negotiation, system mastery, process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. Lead site budget development using FMV, historical benchmarks, and standard-of-care analysis to optimize cost and accelerate signature, ensuring responsible financial stewardship.. Serve as the primary interface with Legal to customize and execute CSAs, MSAs, an”
Industry & Context.
solving hard problems
What They're Looking For.
Must Have
Bachelor’s degree in a relevant Life Sciences, Legal, or Business discipline, Proven experience in Study Management and Contract Negotiation within a pharmaceutical, CRO, or clinical background, Advanced knowledge of ICH/GCP guidelines, clinical-regulatory requirements, and electronic document management systems (e. g. , Veeva Vault, CTMS), ability to influence internal stakeholders and external institutions to secure favorable contract terms and meet project milestones
Nice to Have
Advanced degree (MSc, PhD, or JD) or professional clinical research certification (CCRP, PMP), Specific expertise in cell therapy study delivery, Experience with automated payment schedules and financial forecasting within clinical trials
What You'll Do.
Lead site budget development using FMV
historical benchmarks
and standard-of-care analysis to optimize cost and accelerate signature
ensuring responsible financial stewardship.
Serve as the primary interface with Legal to customize and execute CSAs
and negotiate informed consent language and financial obligations to uphold ethical and compliant practices.
Drive site activation performance by managing timelines and dependencies
engaging proactively to meet SIV dates and compress time to first-patient-in.
and consistency of study manage timely upload of regulatory materials to the Global Electronic Library to ensure visibility and standardization.
accurate capture of all contract and study-related documents in the TMF and contracting systems to maintain inspection readiness and data integrity.
Act as a technical owner for study delivery develop dashboards and trackers for materials
and administrative tasks to provide real-time transparency and drive decisions.
Partner with Data Management Centers to enable seamless flow of study documents and clinical-regulatory data across systems
reducing friction and cycle time.
Identify gaps in study delivery design and embed practical improvements that enhance business continuity and regulatory mentor teams to scale best practices.
How You'll Work.
Team & Collaboration
connective force linking Legal, Clinical Operations, and trial sites; collaborate with experts across disciplines—imagine clinical contracts specialists, biomarker scientists, trial physicians, and data modelers solving hard problems side by side
Communication Scope
sharp negotiation; influence internal stakeholders and external institutions
Process & Methodology
managing timelines and dependencies, compress time to first-patient-in, PMP
Full Job Description
Are you ready to convert sharp negotiation and system mastery into faster cell therapy site activations that bring novel therapies to patients sooner? This role puts you at the center of study launch—aligning budgets, legal terms, and data flows to deliver operational clarity and speed. You will be the connective force linking Legal, Clinical Operations, and trial sites, orchestrating everything from initial site identification and contract execution through to audit-ready documentation and operational reporting. With a deep and diverse cell therapy portfolio, your work will directly influence first-patient-in timelines, financial integrity, and the quality of our study execution. How will you apply your expertise to accelerate study readiness while safeguarding compliance and value? **Accountabilities:** * Contract Strategy and Budget Negotiation: Lead site budget development using FMV, historical benchmarks, and standard-of-care analysis to optimize cost and accelerate signature, ensuring responsible financial stewardship. * Legal Partnering and Agreement Execution: Serve as the primary interface with Legal to customize and execute CSAs, MSAs, and CDAs; negotiate informed consent language and financial obligations to uphold ethical and compliant practices. * Site Start-up Leadership: Drive site activation performance by managing timelines and dependencies, engaging proactively to meet SIV dates and compress time to first-patient-in. * Document and Template Stewardship: Oversee creation, version control, and consistency of study documents; manage timely upload of regulatory materials to the Global Electronic Library to ensure visibility and standardization. * TMF and Audit Readiness: Ensure complete, accurate capture of all contract and study-related documents in the TMF and contracting systems to maintain inspection readiness and data integrity. * Tools and Reporting Ownership: Act as a technical owner for study delivery tools; develop dashboards and trackers for
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