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Reference Number:
10-11020
Job Description:
Focus and Scope:
- Responsible for the management of all clinical supplies during trial execution within Pharma R&D (large and small molecules and for all phases of clinical trials) consistent with GMP guidelines.
Description of the Role:
- Adopt supply strategies in view of changes in trial execution and ensure a seamless transition from study design phase.
- Assess clinical study recruitment rates and ensure supply planning is adopted accordingly.
- Utilize IVRS to manage inventories at depots and sites and ensure on-time delivery with minimal overage of clinical supplies.
- Conduct issue resolution activities for supply aspects of clinical studies (e.g., packaging, distribution).
- Establish and modify trial specific distribution agreements
- Develop strong internal collaboration with GCO stakeholders to ensure customer satisfaction.
- Interface with Global Trial Managers.
- Manage trial supply budget.
- Develop excellent working relationships with the other groups within Supply Management.
Experience Level:
5+ Years
Requirements:
Critical Experiences Required:
- A university/bachelor's degree (or equivalent experience) and 4-6 years experience preferably in a clinical supply related role
- Experience with clinical supply demand management tools preferred (e.g., tcVisualize, IVRS, SAP)
- Experience with the following functions preferred: clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, inventory management
- General knowledge of GxP principles
- Intermediate to advanced software skills (e.g., Microsoft Excel, Powerpoint)
Critical Competencies:
- Strong written and verbal communication skills
- Strong planning and cross-functional coordination skills
- Strong attention to detail
- Ability to work independently with some coaching
- Ability to multi-task and manage complexity
- Ability to work in a high pressure environment
- Solution oriented
- Exceptional collaboration skills
- Integrity and Credo Based-actions
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