Manager, Clinical Contracts

Role Summary

The Manager, Clinical Contracts will ensure the successful negotiation and ongoing management of site and vendor clinical trial related agreements and serve as the key liaison between Clinical Operations, Legal, Finance and Accounting departments. This role involves generating, reviewing, finalizing and tracking contracts and budgets, and managing cross-functional communication. This individual will support the clinical team in the planning, execution and control of contracts, applying critical thinking to resolve challenges while maintaining clear communication.

Responsibilities

• Provide comprehensive contract lifecycle management.
• Work with Clinical Operations, Legal, Finance, and other stakeholders to support timely initiation, term review, negotiation, risk assessment, execution and administration of contracts.
• Manage tracking of contracts, amendments and budgets, and provide updates to 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.
• Actively participate in team meetings to expedite contracts to execution.
• Build and maintain strong relationships with clinical sites and vendors.
• Facilitate contract actions and processes independently in a dynamic environment with competing priorities.
• Respond promptly and professionally to inquiries from internal team members and external vendors.
• Demonstrate strong analytical and contract administration skills, with clear verbal and written communication.
• Identify and implement process improvements to enhance efficiency and accountability.
• Ensure compliance with SOPs and regulatory guidelines, addressing QA and audit requests as needed.

Qualifications

• Required: 5+ years’ experience in a contract management position within a biotechnology, pharmaceutical, academia or Clinical Research Organization (CRO).
• Required: Clinical Site Budget experience.
• Preferred: Experience within Global Oncology Phase 1-3 clinical trials.
• Preferred: Grant Plan experience.
• Required: Good knowledge of ICH-GCP, pharmaceutical related regulations and laws.
• Required: Ability to thrive in a fast-paced growing company with minimal direction and ability to adjust to changing priorities.
• Required: Proficiency in Microsoft Excel at an Intermediate level.

Skills

• Strong verbal and written communication.
• Analytical and contract administration capabilities.
• Ability to manage multiple priorities and deadlines.

Education

• Bachelor’s degree required.

Additional Requirements

• Location: On site (San Diego, CA).