AstraZeneca

Study Contracts Manager

AstraZeneca

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $105,735 - $138,777 per year

About the role

  • Template Localization: Adapt global agreement templates for local use, aligning with local requirements and standard operating procedures to ensure consistency and compliance.
  • Fair Market Value Budgeting: Develop and negotiate clinical site budgets based on Fair Market Value to ensure fairness, sustainability, and operational predictability.
  • Site Agreement Negotiation: Negotiate the language and budget terms of agreements with clinical study sites, engaging with site administration where needed, including partner sites.
  • Legal Partnership: Serve as the primary point of contact with Legal, as required, to maintain contract integrity and mitigate risk.
  • Agreement Lifecycle Ownership: Track and maintain the status of each agreement, including budgets, issues, payments, amendments, and communications with all parties for the duration of the study.
  • Contract Finalization: Ensure final contract documents accurately reflect the agreements reached during negotiations, with clean version control.
  • Start-Up Acceleration: Guarantee timely execution of all agreements to contribute to efficient site start-up timelines and study activation.
  • Inspection Readiness: Support internal and external audit activities and maintain complete, defensible documentation.
  • Policy and Code Compliance: Ensure compliance with AstraZeneca’s Code of Conduct and all company policies relating to people, finance, technology, and security.
  • eTMF Stewardship: Ensure that all contracts are filed, maintained, and archived within the electronic Trial Master File (eTMF) to agreed standards.
  • Team Enablement (senior): Train and mentor new members of the local Study Team in financial and contractual matters, sharing relevant experience.
  • Master Service Agreements (senior): Support the preparation and negotiation of a Local Master Service Agreement to streamline site engagement.
  • Continuous Improvement and SME Leadership (senior): Contribute to process improvements, knowledge transfer, and the sharing of best practices—including those related to Fair Market Value—and act as a Subject Matter Expert.

Requirements

  • Bachelor’s degree aligned to the knowledge and skills of the role and ensures successful conduct of responsibilities and appropriate interactions with internal and external collaborators
  • Experience adapting global agreement templates for local use, ensuring alignment with local requirements and standard operating procedures
  • Background in developing and negotiating clinical site budgets based on Fair Market Value
  • Proven ability to negotiate the language and budget terms of agreements with clinical study sites, engaging with site administration as needed, including partner sites
  • Experience serving as the primary point of contact with Legal to maintain contract integrity
  • Proficiency in tracking and maintaining the status of each agreement, including budgets, issues, payments, amendments, and all communications for the duration of the study
  • Ability to ensure final contract documents accurately reflect the agreements reached during negotiations
  • Demonstrated ability to guarantee timely execution of all agreements to contribute to efficient site start-up timelines
  • Experience supporting internal and external audit activities
  • Commitment to compliance with AstraZeneca’s Code of Conduct and all company policies relating to people, finance, technology, and security
  • Experience ensuring that all contracts are filed, maintained, and archived within the electronic Trial Master File (eTMF).
Benefits
  • eligible for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles
  • qualified retirement programs
  • paid time off (i.e., vacation, holiday, and leaves)
  • health, dental, and vision coverage in accordance with the terms of the applicable plans

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
template localizationbudget developmentcontract negotiationagreement lifecycle managementcontract finalizationaudit supporteTMF managementprocess improvementFair Market Value budgetingsubject matter expertise
Soft skills
communicationmentoringcollaborationproblem-solvingattention to detailorganizational skillsleadershipnegotiationadaptabilitytime management
Certifications
Bachelor’s degree