Tech Ops And Quality - Clinical Supply Chain Operations Manager

Manager, Clinical Supply Chain – Operations Cambridge, MA (Hybrid) 6 Months Contract

We are seeking an individual for the role of Manager – Clinical Supply Chain, Operations. In this position, you will play a pivotal role in ensuring reliable, compliant execution of clinical supply across programs, supporting growing pipeline and patient needs. Your focus will be on overseeing end-to-end clinical supply execution activities across assigned protocols, ensuring timely delivery of materials to sites and patients. You will partner closely with cross-functional teams including Clinical Operations, Quality Assurance, Regulatory Affairs, and external vendors to execute clinical trials effectively. Overall, you will be accountable for ensuring uninterrupted supply, managing operational risks, and delivering execution excellence across protocols in a dynamic environment.

Key Responsibilities

• Responsible for end-to-end execution of clinical supply activities including IRT, packaging, labeling, distribution, inventory management, returns, destruction, and study closeout
• Ensure protocol milestones are met on time and in full (e.g., FPI, SIV readiness, on-time delivery to sites/patients)
• Partner cross-functionally with Clinical Operations, QA, Regulatory, and CMOs to ensure efficient and compliant execution
• Manage and escalate day-to-day execution risks including delays, deviations, and supply disruptions with clear escalation and mitigation
• Oversee temperature excursions and supply deviations ensuring appropriate documentation and resolution
• Ensure execution activities are compliant, well-documented, and inspection-ready
• Maintain visibility to inventory levels and supply availability across programs
• Contribute to continuous improvement of execution processes, tools, and ways of working
• Train and mentor fellow trial leads

Qualifications

• B.Sc. in a scientific field or Supply Chain Management or related field
• 4+ years of direct Clinical Supply Chain experience globally
• Demonstrated knowledge of clinical supply chain packaging, labeling, inventory management, global distribution
• Strong understanding of clinical trial operations and drug development lifecycle
• Foundational knowledge of GMP / GxP / GCP and global regulatory requirements (FDA, EU, etc.)
• Experience with systems/tools (IRT/IXRS, inventory systems, Excel, Smartsheet, ERP)
• Risk identification, assessment, and mitigation
• Project management across multiple studies/programs
• Vendor / CMO / CRO management and oversight
• Budget tracking, cost control, and financial oversight of protocols
• Problem-solving and risk-based decision making
• Proficient knowledge of MS Office (Excel, PowerPoint, Visio, Project, etc)
• Excellent communication, attention to detail, collaboration, ability to manage complex challenges, and influencing skills

At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.