Study Contract Manager

AstraZeneca • Santa Monica, CA

11d • $112,154 - $168,232 • Hybrid

About The Position

Are you ready to take on a pivotal role in the Site Activation Team as a Study Contract Manager? Primarily responsible for coordinating the various aspects of clinical trials. Works as part of a clinical delivery team providing support, guidance and advice on a local level. Develops existing tools and processes to identify areas of improvement and ensures business continuity for oncology study delivery. Able to solve complex problems within a range of studies. You will manage and provide leadership during the clinical agreement and site level budget negotiation process to ensure ethical, fair and compliant practices are followed when developing, negotiating and executing clinical agreements and investigator budgets. This position necessitates providing leadership, direction, and guidance through process improvement, interactive communication and stakeholder management. This role requires a high level of interactive communication to set clear direction for the 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. Leverage historical data, negotiation techniques, and address SoC with sites to support the delivery of oncology trials, in 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.
• Be responsible for producing clinical site budget, in collaboration with LSAD, appropriate Payment Schedules based on the Protocol and AZ policy and guidelines to provide to Clinical Delivery Team.
• Formulate and identify the proper agreement template to initiate negotiations.
• Act as point of contact and interface with Legal if necessary to ensure integrity of contracts.
• Drive site start-up time by striving to execute CSA within KPI.
• For each agreement maintain the status of agreement, budgets, issues, and communications with both internal and external sources.
• Attend and engage in scheduled project team meetings.
• Ensure final contract documents are consistent with agreements reached at negotiations.
• Contribute to set-up and execute Master confidentiality agreement and confidentiality agreement with key partner sites, as appropriate locally.
• Ensure all agreements are completed or captured in 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. Ability to process agreement requests and identify 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 that modification.
• Is member of LST, work with study teams to determine priorities for meeting timelines and SIV dates.
• 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, exhibits contract and negotiation expertise to achieve a balance between external business exposure and policies/regulations.
• As a subject matter expert, demonstrates an understanding of how contractual terms add value to internal and external customers.
• As a subject matter expert, possesses 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

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

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