Study Contract Manager

3 weeks ago

Wilmington, United States AstraZeneca Full time

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you are our kind of person.

A position providing 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.

**Major responsibilities**
- Develop and negotiate clinical site budgets based on Fair Market Value. Leverage historical data, negotiation techniques, and address SoC with sites to realize 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 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.
- Function 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.
- 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 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 that modification.
- 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 with preferred or notable Institutions.
- 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 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).

**Additional Responsibilities**
- 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.

**Requirements for the Role**
- Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification
- Strong interpersonal, negotiation, communication, and time management skills.
- Experienced user of FMV tool, specifically MEDIDATA Grant Manager tool.
- Minimum of 5 years’ experience in pharmaceutical or health care industry
- Strong oral, written, and organizational skills.
- Fluent knowledge of spoken and written English.
- Knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
- Good knowledge of relevant local regulations.
- Good medical knowledge in relevant AZ Therapeutic Areas.
- Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data

management.
- Ability to adapt to change
- Ability to travel nationally as required.
- Maintain ability to deliver quality according to the requested standards.
- Demonstrate ability to work in an environment of re

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