Trial Supply Manager

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

• This individual is responsible for the planning and inventory management of clinical supplies during the execution phase of a clinical trial, according to timelines, budget, and all SOP, GMP, and regulatory requirements. They will act as the single point accountable at the trial level.
• The Trial Supply Manager will manage and adjust campaign strategies and inventory management systems, including IVR, IWR, and IRT. Responsibilities also include assessing clinical study enrollment rates and ensuring supply planning supports study enrollment needs.
• The Trial Supply Manager conducts issue resolution activities for supply aspects of clinical trials, including Product Quality Complaints, Events, Temperature Excursions, and Logistic Events.
• They will manage and modify trial Distribution Agreements, Investigational Medicinal Packaging Agreements, relabeling activities, and manage the ICSC budget for a trial.
• This individual will deliver an audit-ready clinical trial package, including CSR and all required documentation, and identify and implement improvements impacting specific trials/compounds.
• The Trial Supply Manager modifies supply strategies as needed based on changes in trial execution, ensuring a seamless transition from study design. They will also assess recruitment rates and adjust supply planning accordingly, utilizing business tools like IVRS to manage inventories and ensure on-time delivery with minimal overage.
• As a member of the technical team, they will develop strong internal collaboration with GCO stakeholders to ensure customer satisfaction, interface with Global Trial Managers, and manage trial supply budgets. They will develop excellent working relationships within the Clinical Supply Chain.

• A minimum of a Bachelor's Degree and 4 years of experience in clinical supplies or a related supply chain role (supply or demand planning), or a minimum of 8 years of relevant experience.
• At least 2 years of experience in multi-disciplinary CSC or Pharma R&D areas (manufacturing, packaging & labeling, logistics, clinical operations, project management) is highly preferred.
• Experience with clinical supply demand management tools such as TC, IVR/IWR/IRT, Forecasting and Simulation, Optimizer, and SAP is highly preferred.
• Experience with functions like S&OP, clinical supply pack/label/distribution, clinical trial operations, project management, and inventory management is highly preferred.
• General knowledge of GxP principles is required.
• Intermediate to advanced skills in Microsoft Excel and PowerPoint, with strong data analysis and problem-solving capabilities.
• Experience in a highly matrixed environment with demonstrated leadership is required.
• Formal project management training and experience are highly preferred.

Thanks!! With Regards,
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Direct:  | (W)  x219

Inc. 5000 –  (9 Years in a row)