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Senior Clinical Supply Chain Planner
$80,000
per year
Job Description
The Clinical Supply Chain Planner is responsible for the end-to-end management and oversight of clinical supply chain activities for assigned clinical protocols. This role works closely with key stakeholders including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs, Contract Manufacturing Organizations (CMOs), and Contract Research Organizations (CROs) to ensure seamless supply of Clinical Trial Material (CTM).
Key Responsibilities:
- Manage clinical supply chain activities for assigned protocols from forecasting through distribution and inventory management.
- Collaborate with Clinical Operations, Quality, Regulatory, CMO, and CRO partners to ensure uninterrupted CTM supply.
- Develop and manage clinical supply forecasts, including supply/demand planning and financial budgeting.
- Oversee the set-up and execution of IRT/UAT systems and processes.
- Manage packaging and labeling activities, including experience with booklet labels, translations, global study requirements, and production requests.
- Support documentation management, including eTMF filing of clinical supply documents.
- Monitor and manage vendor performance for contract manufacturing and distribution activities.
- Proactively identify risks, communicate effectively, and escalate issues to meet project timelines.
- Work cross-functionally with internal and external partners, including clinical operations and stability teams.
- Support a collaborative environment and contribute to continuous improvement initiatives.
Qualifications:
- Bachelor’s degree in a relevant field (e.g., Supply Chain, Life Sciences, Business) preferred.
- Minimum 3 years of clinical supply chain planning experience; ideally 3–7 years.
- Experience with supply and demand forecasting.
- Proficiency with IRT/UAT system set-up and execution.
- Experience working cross-functionally with Clinical Operations, stability teams, and CMOs.
- Strong understanding of packaging and labeling processes for clinical supplies, including global studies and regulatory requirements.
- Ability to work independently, prioritize workload, and manage multiple projects in a fast-paced environment.
- Excellent communication and organizational skills.
- Proficient in Microsoft Office (Word, Excel, PowerPoint) and clinical systems (e.g., IRT).
Work Arrangement:
- Hybrid schedule: Initially 3 days onsite (Tuesday–Thursday); transition to 2 days onsite (Tuesday & Wednesday) once trained and up to speed.
Company Information
Location: Cambridge, MA
Type: Hybrid