We are currently seeking a CONTRACT Clinical Supply Chain Manager in our Durham, NC headquarters. The selected individual will provide oversight of clinical and non-clinical supplies, track inventory levels/manage expiry dates, and liase with Clinical Project teams.
- Contract oversight for CMC related vendors.
- Review and negotiate vendor contracts/proposals, initiate POs, and process all invoices for payment.
- Assisting in the scheduling and maintaining of all vendor activities/campaigns related to manufacturing, packaging, labeling, and distribution by working closely with vendor Business Development & Project Managers.
- Maintain communication with vendors as primary contact; escalating project status and any issues with supervisor as appropriate.
- Coordinate overall CTM inventory to support upcoming clinical studies.
- Coordinate and complete CMC documentation for IND submissions (i.e. Annual Reports, IND Amendments, etc.)
- File and maintain API and Finished Product batch records per the requirements of Chimerix SOPs.
- Process documentation for proper internal release of each batch of API and CTM for use in clinical trials.
- Request CTM for clinical studies and maintain related documentation according to Chimerix SOPs.
- Review and approve IVR/IWRS specifications to fulfill the design of each clinical study along with the Clinical Program Manager.
- Employ and manage the IVR/IWRS throughout the duration of the clinical study.