Job Summary
It's more than just something that fills our days. At Thermo Fisher Scientific, our work has a purpose. Our work requires passion and creates meaningful outcomes. Our work matters. We're sharing our expertise and technological advancements with customers, helping them make the world a better place - whether they're discovering a cure for cancer, protecting the environment or making sure our food is safe.
Responsibilities:
- Designs and implements strategic plans to forecast and supply study drug to global clinical trials using sound supply chain techniques
- Devises and implements inventory management plans that have complex supply chains
- Creation, reviews, interprets and implements supply forecast plans from internal or external source documents and tools.
- Provides input into user requirement specifications of Interactive Response Technology (IRT) medication management module as needed.
- Reviews IRT strategy to ensure it supports the strategic supply plans and ensures that IRT settings are adjusted to optimize the supply chain, combined effort with the Distribution PM
- Executes and documents IRT User Acceptance Testing, if required.
- Maintains documents according to guidelines and relevant procedures
- Executes supply chain inventory management processes in partnership with internal Clinical Supply Optimization Services team members and packaging partners.
- Serves as the global project lead on assigned projects, ensuring internal project resources are focused on delivery and client satisfaction
- Plans and manages execution of initial supplies and resupplies for assigned studies
- Use Simulation as a forecasting tool together with one of the Simulation experts
- Presentation of Simulation Outputs to clients
- Ensures temperature excursion process is executed as required
- Proactively identifies potential supply chain issues, provides analysis and recommends solutions
- Performs study close out activities including returned good reconciliation, inventory destruction processing, and file archiving - KPI
- Summarizes data, prepares presentations and makes recommendations for action relative to the clinical supply chain and packaging plans
- Develops and provides client(s) with reports on actual project spend versus budget
- Negotiates effectively with clients regarding study plan without damaging relationships
- Provides recommendations on packaging design, distribution (Distribution PM) and blinding strategy with existing clients
- Works with both internal and client Project teams to ensure consistent communication of clinical trial material supply status. Identifies potential risks, defines and executes risk mitigation plans.
- Takes lead in developing solutions to solve issues with existing clients and projects
- Leverages understanding of Fisher resources to propose solutions to clients
- Identifies, recommends, and leads process improvement initiatives
- Supports communication of best practice through shared learning sessions, contribution to guidelines and SOPs
- Identifies new CSOS and other service line opportunities with existing clients and engages Business Development resources accordingly
- Establishes and maintains financial forecasts and monthly billing processes for assigned client projects
- Recognizes contracted scope of services and connects with the appropriate resources for extensions of service
- Develops and administers training on CSOS business processes
- Assists in training and on boarding of new employees (buddy concept)
- Conducts activities in a safe and efficient manner
- Demonstrates and promotes the company vision.
- Stays abreast of relevant GxP and other regulatory requirements and ensures study management activities are aligned
- Other duties may be assigned to meet the needs of the business
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