Astrazeneca
pharmaceutical
StudyContractsManager
“Study Contracts Manager at Astrazeneca. Skills: Study Contracts Management, Clinical Trial Agreements, Site Activation, Budget Negotiation. Coordinating the various aspects of clinical trials. Providing support, guidance and advice on a local level”
What You'll Achieve.
Ensure ethical, fair and compliant practices are followed; Timely study start-up; Optimizing cost savings; Execute CSA within KPI; Maintain status of agreement, budgets, issues, and communications; Ensure integrity of contracts; Achieve a balance between external business exposure and policies/regulations; Maintain and develop the effectiveness of the Clinical Study Agreement & Grant Management processes; Ensure compliance with AstraZeneca’s Code of Conduct and company policies; Ensure timely customization and completion of the CSA; Ensure compliance with ICH/GCP and AZ Procedural documents; Ensure all study documents are ready for final archiving and sign-off completion
Industry & Context.
Able to solve complex problems within a range of studies
Hybrid Role Onsite
What They're Looking For.
Must Have
Bachelor’s degree in relevant discipline, Experience of Study Management within a pharmaceutical or clinical background, Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management
Nice to Have
Advanced degree within the field, Professional certification, Understanding of multiple aspects within Study Management
What You'll Do.
Coordinating the various aspects of clinical trials
guidance and advice on a local level
Developing existing tools and processes to identify areas of improvement
Ensuring business continuity for oncology study delivery
Managing and providing leadership during the clinical agreement and site level budget negotiation process
negotiating and executing clinical agreements and investigator budgets
and guidance through process improvement
interactive communication and stakeholder management
Setting clear direction for the study teams and external Institutions
Developing and negotiating clinical site budgets based on Fair Market Value
Leveraging historical data
negotiation techniques
and addressing SoC with sites
Negotiating agreement language with clinical study sites
Producing clinical site budget and appropriate Payment Schedules
Formulating and identifying the proper agreement template
Acting as point of contact and interface with Legal
Driving site start-up time by striving to execute CSA within KPI
Maintaining the status of agreement
Ensuring final contract documents are consistent with agreements reached at negotiations
Contributing to set-up and execute Master confidentiality agreement and confidentiality agreement
Ensuring all agreements are completed or captured in contracting system
Supporting internal and external audits and litigation activities
Negotiating appropriate terms and conditions of Informed Consent Forms and other Clinical Agreements
Approving Clinical Study Agreements with final signature
Negotiating a variety of common contractual issues
Processing amendments to contracts
Working with study teams to determine priorities for meeting timelines and SIV dates
Serving as a liaison between the legal and clinical trial teams
Negotiating master templates and rate cards with preferred or notable Institutions
Achieving a balance between external business exposure and policies/regulations
Demonstrating an understanding of how contractual terms add value
Communicating confidently and competently
Liaising with others through excellent communication and negotiation skills
Ensuring compliance with AstraZeneca’s Code of Conduct and company policies
Ensuring timely customization and completion of the CSA for designated studies
Participating in training and mentoring of new members
Ensuring that all study documents are ready for final archiving
Contributing to process improvements
knowledge transfer and best practice sharing
How You'll Work.
Team & Collaboration
Works as part of a clinical delivery team; Interactive communication and stakeholder management; High level of interactive communication to set clear direction for study teams and external Institutions; Collaboration with LSAD; Collaboration with Legal; Collaboration with Clinical Delivery Team; Collaboration with project team meetings; Collaboration with study teams; Collaboration with LST; Collaboration with legal and clinical trial teams; Collaboration with key partner sites; Collaboration with preferred or notable Institutions; Collaboration with internal and external sources; Collaboration with new members of the local Study Delivery Team
Communication Scope
Interactive communication; High level of interactive communication; Excellent communication skills; Communicate confidently and competently
Process & Methodology
Managing clinical trials, Ensuring business continuity for oncology study delivery, Driving site start-up time, Meeting timelines, Meeting SIV dates, Schedule/cost forecasting, Risk management
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