Site Contract Manager

Clinical Business Operations Site Contract Manager

The Clinical Business Operations (CBO) Site Contract Manager, is responsible for managing contracting activities in support of clinical studies in alignment with Shionogi Inc. (SI) mission and objectives. Reporting to the Associate Director, Site Contracting, this role oversees the preparation, negotiation, and execution of confidentiality agreements (CDAs), clinical trial agreements (CTAs), and amendments for assigned clinical studies.

This role requires close collaboration with clinical trial teams and CROs to support timely study start-up and operational efficiency. The CBO Site Contract Manager is responsible for verifying and tracking negotiated cost savings and works with internal and external stakeholders including Legal, Regulatory, Compliance, and Finance to finalize contracts and implement revisions as needed.

Responsibilities

• Manage the full lifecycle of clinical agreements and budgets, including CDAs, CTAs, and amendments.
• Oversee CRO led negotiations and execute site contracts to align with study timelines and organizational objectives.
• Collaborate cross-functionally with Legal and Clinical Operations to finalize contract terms, and address complex issues, serving as the primary escalation point for CRO teams for outsourced studies :
• Direct setup, escalations, and review of global site budgets and contracts from CRO partners and internal stakeholders to ensure timely contract execution and study startup forecasts are achieved.
• Provide oversight to CROs to ensure negotiation timelines, cost parameters and deliverables are met.
• Support the development, negotiation, and maintenance of master clinical trial agreements and related templates.
• Identify risks, mitigate potential delays, and escalate non-performance issues to ensure sites are "Ready to Enroll."
• Exercise independent judgment to resolve contract and budget issues within defined thresholds, escalating only when necessary.
• Ensure all clinical agreements comply with applicable regulatory, legal, financial, and corporate policies, proactively identifying and addressing potential compliance or risk concerns.
• Monitor investigator spend to ensure alignment with approved studies budget.
• Build and maintain effective relationships with internal teams and external stakeholders to facilitate efficient contract execution.
• Track and report key performance metrics, including contract cycle times, cost savings, and adherence to KPIs, providing monthly and ad hoc updates to the Associate Director, Site Contracting.
• Drive measurable improvements in contract execution timelines, negotiation efficiency, and overall process quality.
• Provide expert negotiation support to resolve complex contract or budget issues and achieve mutually acceptable outcomes.
• Contribute to continuous improvement initiatives to enhance site contract processes, templates, and vendor oversight practices.
• Other duties as assigned.

Minimum Job Requirements

Qualifications :

Competencies :

Other Requirements :

Additional Information :

The base salary range for this full-time position is $120,000- $150,000. Individual pay is determined by several factors, which include but are not limited to : job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role.

EEO

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.

If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.