Clinical Supply Chain Manager
12-month contract with likely extension
The clinical supply manager is responsible for the development and maintenance of investigational material supply plans and strategies for early and late stage clinical trials. The manager collaborates cross functions to proactively assemble key processes necessary to generate approvable clinical supply strategies and plans. The role will also work closely with vendors and internal support resources to ensure the on-time execution of activities in order to meet supply milestones.
• Review of clinical protocols and the development of supply chain strategies that align with the clinical study plan, milestones, and the clinical development plan.
• Experienced with clinical study design, the manager contributes to supply strategy to minimize drug supply and patient compliance risks.
• Collaborates to drive key decisions required to develop supply strategies and study objectives.
• Experience with planning and execution of clinical supply packaging, labeling, and logistics events with vendors
• Collaborates with vendors and internally to develop the strategy for labels, packaging, distribution and returns strategies.
• Contributes to the development of IRT system user requirements (URS) and user acceptance testing
• Responsible for monitoring/facilitating drug supply events within IRT from study start-up through study closure
• Develops demand/supply forecast and communicates plans to key stakeholders
• Responsible to develop clinical supply budget and monitoring expenditures against the supply budget.
• 5 Years of Clinical Supply Management experience within biotech or pharma
• Experience with demand/supply forecasting
• Demonstrated experience working with clinical supply vendors.
• Knowledge of temperature-controlled distribution, import/export and shipping
• Demonstrated experience in global clinical supply forecasting and planning
• Experience with packaging and labeling operations
• Experience with clinical trial design
• Experience with IRT URS development and UAT.
• Broad knowledge of and experience with cGMP, GDP and GCP standards and guidance documents such as Annex 13.
• Four-year degree
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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