Study Contracts Manager

AstraZeneca • Wilmington, DE

1d • $105,735 - $158,603 • Hybrid

About The Position

This role is part of the Site Activation Team and is primarily responsible for coordinating various aspects of clinical trials. The Study Contracts Manager works as part of a clinical delivery team, providing support, guidance, and advice on a local level. This position involves developing existing tools and processes to identify areas of improvement and ensuring business continuity for oncology study delivery. The role requires the ability to solve complex problems within a range of studies. The Study Contracts Manager will manage and provide leadership during the clinical agreement and site level budget negotiation process, ensuring ethical, fair, and compliant practices are followed. This position necessitates providing leadership, direction, and guidance through process improvement, interactive communication, and stakeholder management, requiring a high level of interactive communication to set clear direction for study teams and external institutions.

Requirements

• 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 Haves

• Advanced degree within the field
• Professional certification
• Understanding of multiple aspects within Study Management

Responsibilities

• Develop (in collaboration with the LSAD in charge of the study) and negotiate clinical site budgets based on Fair Market Value, leveraging historical data, negotiation techniques, and addressing SoC with sites to support the delivery of oncology trials within the scope of study budget with optimizing cost savings.
• Negotiate agreement language with clinical study sites to reach a shared understanding of deliverables, a timely study start-up, and financial obligations.
• Produce clinical site budget, in collaboration with LSAD, and appropriate Payment Schedules based on the Protocol and AZ policy and guidelines to provide to the Clinical Delivery Team.
• Formulate and identify the proper agreement template to initiate negotiations.
• Act as a point of contact and interface with Legal if necessary to ensure the integrity of contracts.
• Drive site start-up time by striving to execute CSA within KPI.
• Maintain the status of agreements, budgets, issues, and communications with both internal and external sources for each agreement.
• Attend and engage in scheduled project team meetings.
• Ensure final contract documents are consistent with agreements reached at negotiations.
• Contribute to the set-up and execution of Master Confidentiality Agreements and Confidentiality Agreements with key partner sites, as appropriate locally.
• Ensure all agreements are completed or captured in the contracting system.
• Support internal and external audits and litigation activities.
• Negotiate appropriate terms and conditions of Informed Consent Forms and other Clinical Agreements and associated documents.
• Process agreement requests and identify the correct legal entity and template to be used.
• Approve Clinical Study Agreements with final signature, according to Delegation of Authority.
• Negotiate a variety of common contractual issues related to standard template agreements.
• Process amendments to contracts, as necessary, and manage those modifications.
• Serve as a liaison between the legal and clinical trial teams.
• Negotiate master templates and rate cards with preferred or notable Institutions, including the creation, implementation, and following of specific partnering MSA with key oncology Institutions.
• As a subject matter expert, exhibit contract and negotiation expertise to achieve a balance between external business exposure and policies/regulations.
• As a subject matter expert, demonstrate an understanding of how contractual terms add value to internal and external customers.
• As a subject matter expert, possess detailed and in-depth knowledge of contract precepts, the contracting process, and budget development.
• Communicate confidently and competently to liaise with others through excellent communication and negotiation skills.
• Demonstrate a strong understanding of how the contracting and budget processes contribute to Project Management practices (schedule/cost forecasting and risk management).
• Demonstrate accurate knowledge of regulations and policies in order to maintain and develop the effectiveness of the Clinical Study Agreement & Grant Management processes.
• Demonstrate ability to follow and work within processes.
• Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
• Ensure timely customization and completion of the CSA for designated studies.
• Participate in training and mentoring of new members of the local Study Delivery Team ensuring compliance with ICH/GCP and AZ Procedural documents.
• Ensure that all study documents are ready for final archiving and sign-off completion of the local part of the Trial Master File.
• Contribute to process improvements, knowledge transfer and best practice sharing.

Benefits

• 401(k) plan
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage
• short-term incentive bonus opportunity
• equity-based long-term incentive program (salaried roles)
• retirement contribution (hourly roles)
• commission payment eligibility (sales roles)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level