Senior Manager, Clinical Contracts

The Senior Manager, Clinical Contracts will ensure the successful negotiation and ongoing management of clinical trial-related agreements and serve as the key liaison between Clinical Operations, Legal, Finance and Accounting departments. This role involves but is not limited to generating, reviewing, finalizing and tracking contracts and budgets, and managing cross-functional communication. This individual will be expected to support the clinical team in the planning, execution and control of contracts. The ideal candidate tasks effectively and applies critical thinking to resolve challenges while maintaining clear communication.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Provide comprehensive contract lifecycle management.
• Work closely with Clinical Operations, Legal, Finance, and other internal and external stakeholders to support the timely initiation, contractual term review, negotiation, risk assessment, execution and administration or contracts.
• Manage tracking of contracts, amendments and budgets, and provide updates to the project and cross-functional teams.
• Serve as point person for contracts with internal and external stakeholders.
• Support RFx and Vendor Management activities.
• Support internal oversight of site payment management.
• Establish contracting SOPs and guidance documents.
• Active participation in team meetings for the purpose of expediting contracts to execution.
• Build and maintain strong relationships with external customers, investigators, and vendors.
• Facilitate contract actions and processes independently and effectively in a dynamic environment with competing priorities.
• Respond promptly and professionally to inquiries from internal team members and external vendors.
• Strong analytical and contract administration skills, verbal and written communication skills.
• Identify and implement process improvements to enhance efficiency and accountability.
• Ensure compliance with SOPs and regulatory guidelines, addressing QA and audit requests as needed.

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

• Bachelor’s degree required.
• 8+ years of contract management experience within the biotechnology or pharmaceutical industry preferred. Experience within academia or a Clinical Research Organization (CRO) may also be considered based on the overall strength and relevance of the candidate's background.
• Clinical Site Budget experience necessary.
• Strong experience with global Phase 1-3 clinical trials. Oncology clinical trial experience preferred.
• Grant Plan experience a plus.
• Good knowledge of ICH-GCP, pharmaceutical related regulations and laws.
• Ability to thrive in a fast-paced growing company with minimal direction and ability to adjust to changing priorities.
• Proficiency in Microsoft Excel at an Intermediate level required.