Our client is a fast growing highly profitable multinational biotechnology company with an exciting pipeline of drug compounds at an advanced stage in research. With a hugely experienced and successful executive management team this company has a newly created vacancy for an experienced Clinical Supply Chain Manager. This newly created management position will be located in Dublin.
The Clinical Supply Chain Manager is responsible for managing and insuring timely supply of clinical trial materials for clinical studies at all stages of development. Responsibilities include cross functional planning for clinical demand and forecasting, management of supply chain vendors, inventory management at depots and sites, order management, import and export of GMP drug substance and drug product, returns and destruction.
• Support labeling & packaging operations for clinical studies (Phase 1, 2 and 3)
- Coordinate and manage distribution of Investigational products to depots and sites for clinical studies
- Manage clinical packaging/distribution vendors including negotiating contracts, reviewing batch documentation, designing and developing the distribution instructions
- Participate in the setup, testing and operation of interactive supply tracking systems.
- Serve as the interface between the CMC and clinical teams to ensure smooth conduct of clinical studies.
- Review departmental SOPs and ensure compliance with industry standards
- Coordinate import and export of GMP materials.
- Maintain inventory database, systems and documentation related to material receipt, storage and distribution in compliance with regulatory requirements.
- Ensure compliance with Good Manufacturing Practices (GMP) and applicable state and federal regulatory requirements
- BS or MS degree in chemistry, pharmacy, science, engineering or related fields
- Minimum 5-6 years industry experience in clinical operations or supply chain management for late stage (Phase 3) multi-national clinical trials.
- Experience with managing contract organizations for clinical labeling, packaging and distribution including cold chain
- Experience with clinical blinding practices and IWRS systems
- Familiarity with cGMPs.
- Working knowledge of import and export requirements in a regulated environment.
- Team player with demonstrated strong interpersonal skills, clear oral and written communication skills
- Exceptional attention to detail, strong computer and organizational skills
- Proficiency with Microsoft Office Suite, strong Excel skill with experience building and maintaining drug forecast and distribution trackers and/or clinical inventory management system.
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