Description
Essential duties and responsibilities Include but are not limited to the following:-
The Clinical Supply Chain Coordinator will coordinate with Clinical Operations to assure CTM supply to sites. -
Responsible for coordinating/tracking bulk shipments and depot-depot shipments. -
Track and communicate CTM depot level inventories. -
Initiate and review distribution instructions and protocols. -
Review and approve reconciliation reports. -
Work with manufacturing monitors and CMOs to create and review packaging plans, resolve issues and support the packaging activities. -
Interact as needed with other clinical service providers. -
Assist Clinical Operations as needed in distribution, handling complaints, returns and destruction of CTM. -
Other activities as requested. -
Limited travel.
Requirements:
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1-3 years experience in a GXP environment. -
2+ years experience in clinical supply management. -
Proficient in Microsoft Office Platform. -
Experience in working with CMOs in a virtual environment. -
Ability to develop timelines and monitor activities required to meet clinical study needs. -
Working knowledge of clinical cGMPs and regional regulatory requirements for clinical materials and labels. -
Excellent team skills. -
Good written and verbal communication skills. -
Ability to work on a computer for extended periods of time. -
Regularly required to sit for long periods of time. -
Regularly required to use hands to operate computer and other office equipment.
Education:
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Degree in related science or pharmaceutical related field or supply chain management or related experience.