Senior Manager/Manager, Clinical Business Operations

Shionogi - Florham Park, NJ

Full-time - Mid Level

Florham Park, NJ

Merchant Wholesalers, Nondurable Goods

About the position

The Senior Manager/Manager of Clinical Business Operations is responsible for overseeing clinical outsourcing and managing relationships with vendors and CROs. This role involves vendor selection, contract management, and ensuring that clinical programs are executed within budget while adhering to regulatory guidelines. The position requires collaboration with various internal and external stakeholders to support clinical development programs effectively.

Responsibilities

• Research, review and assess potential CROs and vendors based on needs.
• Work with Clinical Development on planning and management of clinical study related outsourcing activities.
• Collaborate with global functions on supporting outsourcing activities.
• Facilitate creation and execution of all contract documents and manage contract negotiations.
• Build and maintain business relationships with CROs, vendors, and external partners.
• Ensure clinical programs are executed within projected budget and communicate any changes promptly.
• Collaborate with Finance on management of the latest estimate and planning activities for Clinical.
• Manage all activities in accordance with company SOPs, FDA, & ICH guidelines.

Requirements

• Bachelor's Degree or equivalent education required, preferably in Life Sciences, Finance, or Business; MBA is a plus.
• 4-5 years experience for manager and 5-6 years for senior manager in outsourcing for clinical trials, vendor negotiations, or operations management.
• Pharmaceutical industry experience preferred, particularly in Research and Development functions.
• Excellent written and oral communication skills with ability to generate concise reports and verbal updates.
• Strong analytical skills and proficiency with Microsoft Office suite and Adobe.

Nice-to-haves

• Experience dealing with a Clinical Development department and Global clinical trial experience.
• Proficiency in Excel including pivot tables, database & lookup formulas.