Clinical Supply Chain Operations Manager

Overview
We are seeking a Manager, Clinical Supply Chain – Operations for our well known client in Cambridge, MA. They will play a key role in ensuring reliable, compliant execution of clinical supply activities across multiple clinical programs and patient populations.
This individual will oversee end-to-end clinical supply execution activities for assigned protocols, ensuring timely and efficient delivery of materials to clinical sites and patients. The role partners closely with cross-functional stakeholders, including Clinical Operations, Quality Assurance, Regulatory Affairs, and external vendors, to support successful clinical trial execution.
The ideal candidate will be responsible for maintaining uninterrupted supply, proactively managing operational risks, and driving execution excellence in a fast-paced and dynamic environment.
This is a hybrid position based primarily in the Cambridge, MA office.

Key Responsibilities

• Lead end-to-end execution of clinical supply activities, including IRT management, packaging, labeling, distribution, inventory management, returns, destruction, and study closeout activities.
• Ensure protocol milestones are achieved on time and in full, including FPI, SIV readiness, and timely delivery to sites and patients.
• Collaborate cross-functionally with Clinical Operations, Quality Assurance, Regulatory Affairs, CMOs, and external vendors to ensure compliant and efficient trial execution.
• Identify, manage, and escalate operational risks, including delays, deviations, and supply disruptions, while driving mitigation strategies and resolution plans.
• Oversee temperature excursions and supply deviations, ensuring appropriate investigation, documentation, and resolution.
• Ensure all execution activities are compliant, properly documented, and inspection-ready.
• Maintain visibility into inventory levels and supply availability across assigned programs.
• Support continuous improvement initiatives related to operational processes, systems, tools, and best practices.
• Train, mentor, and support fellow trial leads as needed.

• Bachelor’s degree in a scientific discipline, Supply Chain Management, or related field.
• 4 years of global Clinical Supply Chain experience within the pharmaceutical, biotechnology, or CRO industry.
• Demonstrated experience with clinical supply chain operations, including packaging, labeling, inventory management, and global distribution.
• Strong understanding of clinical trial operations and the drug development lifecycle.
• Foundational knowledge of GMP, GxP, GCP, and global regulatory requirements (FDA, EMA, etc.).
• Experience with clinical supply systems and tools such as IRT/IXRS, inventory management systems, ERP platforms, Excel, and Smartsheet.
• Proven ability to identify, assess, and mitigate operational risks.
• Experience managing multiple studies and programs simultaneously.
• Vendor, CMO, and CRO management and oversight experience.
• Budget tracking, cost management, and financial oversight experience related to clinical protocols.
• Strong problem-solving skills with a risk-based decision-making approach.
• Proficiency with Microsoft Office applications, including Excel, PowerPoint, Visio, and Project.
• Excellent communication, collaboration, organizational, and stakeholder management skills, with strong attention to detail and the ability to manage complex operational challenges.

#MSPTalent

36441




Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.