• Location: Cambridge, MA
• Type: Temporary
• Job #5015

Clinical Supply Chain, Supply Planner

Description:
Reason: New Contingent Hire
Department: Supply Chain
Job Category: Clinical Operations

Duties:

Job Summary 

Clinical Supply Chain Supply Planner supports programs and protocols, in tandem with program leads.  Interact with internal and external customers and suppliers in order to accomplish project objectives including packaging, labeling, shipment, inventory management, and drug return logistical activities. He/She manages and maintains IMP distribution and returns drug plans and manages Clinical Supply documentation associated with assigned program, in compliance with GMP and industry standards.  The Supply Planner also monitors inventory levels and provides feedback to Program leads and their direct Manager regarding expiry and re-supply needs across inventory.  If required participates in clinical supply group’s system enhancement initiatives, as assigned and needed. The clinical supply chain, supply planner, has exceptional communication skills, self-motivated, exposure and/or knowledge of software programs including Microsoft Project, Power Point, MS Project, Interactive Response Technology (IRT), and Microsoft Office.  Willingness to learn and sense of urgency to meet patient and program needs.  Experience with CGMP and/or CGCP is a plus.Accountabilities • Work actively and align with Clinical Operation/Study team to help create forecast for assigned study and program including enrollment rate.

• Support country logistics for shipping and importation, on assigned study or program.
• Monitor regularly drug expiry, and the appropriate inventory levels across assigned clinical programs. 
• Support and oversight of packaging requirements for programs and/or protocols assigned
• Monitoring of enrollment, drop-out rates and actual supply need on assigned protocols and/or programs. Ensure continuous re-assessment of Project needs, on assigned programs and/or protocols.
• Lead label creation and approvals process, including translations for all countries, on assigned study and/or program responsible for. 
• Supports return and destruction of IMPs from sites to depots for assigned study.
• Interface with other members of the Clinical Supply Chain to provide and obtain information and to ensure on time delivery of assigned study.
• Perform inventory checks and manage inventory levels and cycle count at the vendor yearly on assigned study.
• Manage temperature excursions during transportation on assigned study

Skills:

• Experience in Clinical Supply and Pharmaceutical Development required, along with strong understanding of GMP and GCP 
• Experience in Clinical Supply and Pharmaceutical Development required, along with strong understanding of GMP and GCP 
• Knowledge of Import/export regulations, including pro-forma invoice generation, import regulations, and global trade compliance.
• Experienced working with third-party CMO clinical supply operations.

Education:

• B.Sc. in a scientific field
• Minimum 0-5 years of relevant experience

Skills and Experience:

Key Words:
CGMP
CLINICAL PROGRAMS
DOCUMENTATION
GMP
IMPORT/EXPORT

Additional Skills:

INVENTORY
INVOICE
LOGISTICS
MICROSOFT OFFICE
MICROSOFT PROJECT
MS PROJECT
OPERATIONS
PACKAGING
SHIPPING
SUPPLY CHAIN
SUPPLY PLANNER
GCP

Languages:

English
        Read
        Write
        Speak