Clinical Supply Planning (8615163)

Title: Clinical Supply Planning and Logistics Manager

Duration: 6 Months with extensions

Location: Basking Ridge, NJ

Our client in Basking Ridge, NJ is seeking a Clinical Supply Planning and Logistics Manager to join their team on a long term contract with possible extensions.

Duties:

• 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.

Skills:

• 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

Sthree US is acting as an Employment Business in relation to this vacancy.