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.

• 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

• BS degree in business administration finance science or related field or equivalent on the job experience may be considered.
• Minimum 5 years of experience in clinical research site contracting and budgeting oversight or negotiation with evidence of increasing responsibility within a pharmaceutical company CRO or relevant industry vendor.
• Experience with the pharmaceutical industry and clinical drug development.
• Experience in managing Clinical Study Agreements oversight of investigator budgets and ensuring alignment with Fair Market Value guidelines across global clinical trials.
• Excellent written and oral communication skills with ability to generate concise reports and verbal updates.

Competencies

• High degree of organizational and analytical skills.
• Proven organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• Ability to handle complex budgets.
• Ability to work on complex multi-faceted projects. Experience supporting portfolio-level clinical studies or global contracting processes (if true) with demonstrated ability to drive consistency and efficiency across multiple therapeutic areas.
• Proven negotiation skills and vast knowledge of clinical trial agreements.
• Ability to work well and across functions/teams strong collaborator. Strong interpersonal and communication skills; ability to work effectively across cross-functional teams and with other internal and external stakeholders.
• Demonstrated high level of proficiency with Microsoft Office suite (Outlook Word Excel - including pivot tables database & lookup formulas are a plus PowerPoint) and Adobe.

Other Requirements

• This position does not significant managerial and decision-making authority.
• Ability and willingness to travel approximately 0-5% of the year both domestically and internationally
• Must live a commutable distance to our US Corporate Headquarters in Florham Park NJ. Office presence required at least 50% of the time per month

Additional Information

The base salary range for this full-time position is $120000- $150000. 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.

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.

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