Senior Clinical Supplies Specialist
SRG is looking for a Senior Clinical Supplies Specialist that would report into the Senior Director, Clinical Supplies and support activities related to Clinical Trial Material (Phase I - IV), collaborate with internal and external customers, & partner in compliance internally for GxP requirements along with multinational regulations.
- Review and/or provide Clinical Trials Materials (CTM) supply forecasts based on projected needs of clinical trial study protocols.
- Coordinate supply of CTM, based on study and drug forecasts, with Clinical, Manufacturing and Medical project managers, as well as contract distribution partners.
- Review and manage contracts with appropriate internal and external partners.
- Work collaboratively with other departments for the creation and approval of product labeling.
- Hands-on management of the labeling and packaging operations with multiple vendors.
- Support the development, implementation, and maintenance of IXRS systems of global clinical trials.
- Process manual orders for CTM to be shipped by contractors for all studies operating outside of IXRS automated supply systems.
- Maintain clinical supplies inventory for assigned projects by interfacing with vendors to ensure that inventory systems are kept up-to-date and that final product reconciliation is accurate.
- Ensure that key supply project milestones are met while maintaining open communication on supply plan timelines with internal and external customers and partners.
- Bachelor Degree in life science or in a related field of study.
- 4-5 years of clinical supplies experience including experience with drug planning / forecasting, packaging and labeling, global distribution, as well as clinical supply and cold chain management.
- Strong understanding of QP requirements, EU GDPs, Annex 13, CFR and ICH guidelines, regulations and guidelines governing conduct of clinical studies.
- Strong understanding of IXRS systems and generation of URS and UAT documentation.
- Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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