- This individual is also responsible for the planning and inventory management of clinical supplies during the execution phase of a clinical trial according to timelines and will be responsible to stay within budget, and meet all SOP, GMP and regulatory requirements. This individual will act as the single point accountable at the trial level.
- The Trail Supply Manager will manage and adjust campaign strategies and inventory management systems including IVR, IWR, IRT. The responsibilities of this Trial Supply Manager are to also include: assessing the clinical study enrollment rates and ensuring that supply planning supports study enrollment needs.
- The Trial Supply Manager is responsible for conducting issue resolution activities for supply aspects of the clinical trials. The types of issue resolution that the Trial Supply Manager may encounter are: Product Quality Complaints, Events, Temperature Excursions, and Logistic Events.
- The Trial Supply Manager will manage and modify trial Distribution Agreements, Investigational Medicinal Packaging Agreements; relabeling activities and manage the ICSC budget for a trial.
- This individual will also deliver an audit-ready clinical trial package including CSR and all required documentation and will identify and implement improvements impacting specific trials/compounds.
- The Trial Supply Manager will modify as needed supply strategies in view of changes in trial execution and ensure a seamless transition from study design phase. They will assess clinical study recruitment rates and ensure they adjust their supply planning accordingly. They will also utilize business tools (e.g., IVRS) to manage inventories at depots and sites and ensure on-time delivery with minimal overage of clinical supplies.
- As a member of technical team, the Trial Supply Manager will develop strong internal collaboration with GCO stakeholders to ensure customer satisfaction. They will interface with Global Trial Managers and manage trial supply budget. They will also develop excellent working relationships with the other groups within Clinical Supply Chain.
- A minimum of a Bachelors Degree and 4 years of experience in clinical supplies or a related supply chain role (supply or demand planning) is required OR a minimum of 8 years of experience in clinical supplies or a related supply chain role is required.
- A minimum of 2 years of experience in multi-disciplinary CSC or Pharma R&D areas (manufacturing, packaging & labeling, logistics, supply chain, clinical operations, pharma/bio research R&D, project management) is highly preferred.
- Experience with the following clinical supply demand management tools are highly preferred: TC, IVR/IWR/IRT, Forecasting and Simulation, Optimizer, IVRS, and SAP.
- Experience with any or all of the following functions or processes are highly preferred: S&OP, clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, and inventory management.
- General knowledge of GxP principles is required.
- Intermediate to advanced Microsoft Excel and PowerPoint software skills are required. The successful candidate will have very strong data analysis and problem solving experience.
- Experience in a highly matrixed environment with demonstrated leadership is required..
- Any formal project management training and experience is highly preferred.
Thanks!! With Regards,
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Direct: 732-662-7964 | (W) 732-549-2030 x 219
Inc. 5000 – 2007-2015 (9 Years in a row)
