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 is responsible for overseeing clinical outsourcing and managing relationships with vendors. This role involves vendor selection, contract management, budget negotiations, and ensuring compliance with clinical development programs. The manager will also support the development of clinical contractual agreements and actively manage financial obligations related to clinical operations.

Responsibilities

• Conduct vendor selection through Request for Proposal (RFP) processes, proposal review, and budget negotiations.
• Manage contracts throughout the lifecycle of clinical studies, including setting standards and tracking cost savings.
• Assist in developing effective clinical contractual agreements such as Confidentiality agreements, Master Services Agreements, and Lab Agreements.
• Manage clinical financial obligations and oversee CRO/vendor management.
• Research and assess potential CROs and vendors in collaboration with the Director and colleagues.
• Plan and manage clinical study-related outsourcing activities in coordination with Clinical Development.
• Collaborate with global functions such as Biometrics, Regulatory, and Drug Safety on outsourcing activities.
• Facilitate the creation and execution of contract documents and manage contract negotiations with Legal and Finance.
• Build and maintain relationships with CROs, vendors, and external partners.
• Ensure clinical programs are executed within budget and communicate any changes promptly.
• Collaborate with Finance on management of estimates and planning activities for Clinical.
• Ensure compliance with company SOPs, FDA, and ICH guidelines.

Requirements

• Bachelor's Degree in Life Sciences, Finance, or Business; MBA is a plus.
• Minimum of 4 years of experience in clinical trial outsourcing, vendor negotiations, or operations management.
• Experience in the pharmaceutical industry, particularly in Research and Development functions.
• Strong written and oral communication skills with the ability to generate concise reports.
• Demonstrated analytical skills and proficiency in Microsoft Office, especially Excel.

Nice-to-haves

• Experience with global clinical trials.
• Familiarity with contract management software.

Benefits

• Hybrid work location
• Competitive salary
• Health insurance
• 401k plan
• Paid time off