Manager, Clinical Business Operations

Shionogi - Florham Park, NJ

Full-time - Mid Level

Florham Park, NJ

Merchant Wholesalers, Nondurable Goods

About the position

The Manager, Clinical Business Operations at Shionogi Inc. is responsible for overseeing clinical outsourcing and relationship management activities. This role involves vendor selection, contract management, budget negotiations, and ensuring compliance with clinical development programs. The manager will collaborate with various teams to facilitate effective clinical contractual agreements and maintain strong partnerships with external vendors and CROs.

Responsibilities

• Conduct vendor selection through Request for Proposal (RFP) processes, proposal review, and budget negotiations.
• Manage contracts throughout the lifecycle of clinical studies, ensuring compliance with standards and regulations.
• Assist in developing effective clinical contractual agreements, including Confidentiality agreements and Master Services Agreements.
• Actively manage clinical financial obligations and vendor oversight.
• Research and assess potential CROs and vendors in collaboration with the Director and colleagues.
• Work with Clinical Development on planning and management of outsourcing activities.
• Facilitate the creation and execution of contract documents, managing reviews and negotiations with Legal and Finance teams.
• Build and maintain business relationships with CROs, vendors, and external partners.
• Ensure clinical programs are executed within budget and communicate any changes in scope.
• Collaborate with Finance on management of estimates and planning activities for Clinical operations.

Requirements

• Bachelor's Degree or equivalent education required, preferably in Life Sciences, Finance, or Business.
• A minimum of 4 years of experience in outsourcing for clinical trials, vendor negotiations, or operations management.
• Pharmaceutical industry experience, particularly in Research and Development functions, is strongly preferred.
• Experience with Clinical Development departments and global clinical trial experience is essential.
• Excellent written and oral communication skills, with the ability to generate concise reports and verbal updates.
• Strong analytical skills and proficiency with Microsoft Office suite (Outlook, Word, Excel, PowerPoint) and Adobe.
• Experience working in Excel, including pivot tables and database & lookup formulas.

Nice-to-haves

• MBA is a plus.
• Flexibility and adaptability to changing project priorities.