Clinical Supply Planning and Logistics Manager
- Basking Ridge, NJ
Clinical Supply Planning and Logistics Mgr
- Develops and updates Study Supply Plans in close communication with CSO project Managers.
- Responsible for the Clinical Label Development process which includes creation of master label text, translations, and label proofs.
- Manages CMO documentation reviews (i.e, packaging Batch Record) review and approval process with Quality Assurance and other CSO personnel.
- Works closely with Quality Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.
- Oversees clinical site and depot inventories through the course of a study and ensures alignment with supply forecast and study requirements. Reviews IRT specifications, participates in UAT as requested and maintains settings in IRT to align with supply plans.
- Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation.
- Vendor Management –supports Person in Plant (PIP) activities when packaging operations for DSI are in-process. Supports investigational product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to ship
- Assists in the creation of SOP’s and work instructions specific to CSO Supply Planning as requested.
- Responsible for updating relevant Trial Master Files (TMF) with CSO-related documents
- Supports the CSO PM in executing additional operational and logistical duties as discussed and agreed to by management.
- Acts as point of contact for operational clinical supply matters during the course of a clinical trial including facilitating the review of temperature excursions.
- Good understanding of Pharmaceutical Development, Quality Assurance, and Regulatory (domestic and international).
- Solid knowledge of clinical supply planning, manufacturing, packaging, and labeling.
- Experience in managing third-party contract clinical supply operations/CMO’s.
- Experience managing multiple vendors per project required.
- Import/export knowledge desirable.
- Working in a matrixed environment
- Excellent communication, negotiating, and computer skills.
- Strong team orientation.
- Experience with IRT highly preferred
BS/BA required. Degree in pharmacy or related field preferred. MS or PharmD highly beneficial.
Tuesday, March 10, 2020