Position Summary:

We are seeking a highly motivated and detail-oriented Manager, Clinical Outsourcing and Contracts to support global Phase I-IV clinical trials. The ideal candidate will have a strong background in clinical sourcing, vendor management, and contract negotiation within the pharmaceutical industry. This role will be responsible for managing the full lifecycle of vendor engagement, including Requests for Information (RFI), Requests for Proposals (RFP), vendor evaluation and selection, contract execution, change orders, and agreement closeout.

Key Responsibilities:

• Lead the end-to-end vendor outsourcing process for clinical trials (Phase I-IV), ensuring alignment with project timelines, budgets, and regulatory requirements.
• Prepare and manage RFIs and RFPs to potential vendors, including CROs, central labs, and other clinical service providers.
• Evaluate vendor proposals and participate in selection committees to determine best-fit vendors based on cost, quality, and capability.
• Negotiate contract terms and budgets in collaboration with legal, finance, and clinical teams.
• Draft and execute various types of clinical agreements including Master Service Agreements (MSAs), Work Orders (WOs), Change Orders (COs), and Confidentiality Agreements (CDAs).
• Track and manage the change order process to ensure scope adjustments and budget impacts are clearly documented and approved.
• Maintain accurate records of contract status and ensure timely closeout of all agreements.
• Build and maintain strong relationships with internal stakeholders and external vendors to facilitate effective collaboration.
• Ensure compliance with internal policies and applicable regulatory guidelines (e.g., ICH-GCP, FDA, EMA).
• Identify opportunities for process improvement in vendor outsourcing and contracting operations.

Qualifications:

• Bachelor’s degree in Life Sciences, Business, or related field; advanced degree preferred.
• Minimum of 5 years of relevant experience in the pharmaceutical or biotechnology industry, specifically in clinical outsourcing, contracting, or clinical operations.
• Proven experience managing vendor selection and contract negotiation processes for global clinical trials.
• Strong understanding of clinical trial processes, GCP guidelines, and regulatory requirements.
• Excellent negotiation, project management, and organizational skills.
• Proficiency in Microsoft Office and contract management systems.
• Ability to work effectively in a fast-paced, matrixed environment with cross-functional teams.
• Experience working with global clinical vendors.