Clinical Supply Chain Manager-Remote within the U.S.
The Clinical Supply Chain Manager (CSCM) is responsible for planning and managing designated clinical supply chain Management team activities for the company. This position will work with company clients, packaging sites, depots, Clinical Supply Chain Managers and Drug Supply Coordinators to understand the supply chain requirements, define the supply strategy and manage clinical trial materials on the study or program level.
This is a remote position that can be located anywhere within the U.S. No sponsorship available
- Serves as the global project lead on assigned projects, ensuring internal project resources are focused on delivery and client satisfaction, leading by example and negotiating across geographic and functional lines
- 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.
- Ensures temperature excursion process is executed as required
- Performs study close out activities including returned good reconciliation, inventory destruction processing, and file archiving
- Develops and provides client(s) with reports on actual project spend versus budget
- Negotiates effectively with clients regarding study plan without damaging relationships
Clinical Supply Experience:
- Provides recommendations on packaging design, distribution and blinding strategy
- Plans and manages execution of initial supplies and resupplies for assigned studies
- Designs and implements strategic plans to supply study drug to complex global clinical trials using sound supply chain techniques
- Provides input into user requirement specifications of Interactive Response Technology (IRT) medication management module(s) 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
- Executes IRT User Acceptance Testing, if required
- Leverages the inventory management capabilities of the IRT to appropriately manage studies
Supply Chain Management:
- Devises and implements inventory management plans that have complex supply chains
- Reviews, interprets and implements supply forecast plans from internal or external source documents and tools
- Executes supply chain inventory management processes in partnership with internal Clinical Supply Optimization Services team members and packaging partners.
- Proactively identifies potential supply chain issues, provides analysis and recommends solutions
- Packaging, Labeling and Distribution knowledge is required
- Minimum education requirement, High School Diploma or GED
- Bachelor’s degree or higher in operations management or science-related field (equivalent work experience may be considered)
- Strong Project Management Skills, 2-3 years’ experience
- Minimum of 3 – 5 years clinical supply chain management experience
- Experience with IRT/IXRS/IWVR required.
- Experienced in building and managing forecasts for clinical supply chains
- Knowledge of relevant cGMPs, GCPs, and other regulatory requirements
- Excellent computer skills, including high proficiency with Microsoft Suite including Excel, Word and MS Project as well as the Office 365 environment.
- Significant travel (up to 25%) may be required, including international travel
- Ability to independently manage priorities and workday in a remote setting
- Excellent oral and written communication skills
- Excellent teamwork and interpersonal skills