Clinical Trial Supply Manager - Switzerland
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- Manage clinical trial supply chain operations with outside CROs and CMOs including forecasting for all clinical trials, working closely and collaboratively with our company Clinical Operations, Regulatory Affairs and other R&D functions to design appropriate planning, labeling, packaging and distribution configurations.
- Coordinate outsourcing of labeling, packaging and on-time distribution of clinical trial supply to world-wide clinical sites: ensure the scheduling and timely delivery of all necessary clinical supply materials, such as bulk drug, label and packaging inserts, randomization schemes, packaging and shipping configurations, labeling and distribution plans of all company portfolio projects.
- Ensure that all documentation concerning CTS (Labeling, packaging, distribution, reconciliation) is available complete and correct.
- Ensure that all supplies are controlled and distributed in accordance with GMP, GLP, GCP and GDP regulations.
- Interact with the Clinical CRO and IVRS on supplies, replenishments, returns and destructions.
- Review and archive any blinded documentation until the end of the clinical study.
- Monitor clinical trial supply management invoicing by CMO.
- Represent clinical trial supply chain function on internal and external cross functional teams.
PROFESSIONAL SKILLS & EXPERIENCE
- 10 year-experience with at least 5 year-experience in the pharmaceutical clinical trial supply chain operations, including global clinical trial drug management, such as planning, sourcing, inventory control and logistics.
- Experience managing the drug supply chain for global Phase 1 to 3 studies including knowledge of International packaging regulations, import/export licensure and drug depot utilization.
- Hands-on experience in developing and managing integrated supply chain IT support systems.
- Advanced knowledge of labeling, packaging, inventory management and distribution procedures (particularly IWRS systems) related to the management of clinical trial supplies.
- Deep understanding of drug development and clinical development processes especially clinical trial planning and execution.
- Experience in managing CMOs with clinical trial services.
- Experience in auditing and managing supply chain and drug packing CMOs.
- Knowledge of GMP, GLP, GCP and GDP compliance requirements.
- Knowledge of state of the art industry supply chain control systems including IT packages.
- Knowledge of business related areas: project management, contracts, invoicing, and finance.
PERSONAL SKILLS & COMPETENCIES
- Excellent planning and organization skills.
- Good team player and ability to work in functional matrix organization.
- Good communication, negotiation and interpersonal skills.
- Rigorous, reliable, rapid and precise.
- Self-motivated, pro-active and high sense of initiative.
- Flexible, mature and able to work under pressure.
- Willing to learn new areas of expertise as required for the position.
- Ph.D or M.S. in Chemistry, Biology, Biochemistry, Pharmaceutical Science, Pharmaceutical or Chemical Engineering or related field.
- Complete fluency in English is a must. French is a plus.