Job Description

Clinical Supply Chain Contractor

Fully Remote

6 months w/ renewal

The Role:

The Clinical Supply Chain contractor be responsible for managing investigational drug supplies for one global Phase III oncology trial. They will oversee all aspects of clinical supply management including packaging, labeling, distribution, co-medication sourcing, inventory management, and vendor oversight. They will have an excellent understanding of the clinical supply packaging and labeling processes and be able to independently manage supply needs and distribution.

Key Responsibilities:

·Develop clinical supply packaging and labeling to fulfill clinical study dosing requirements and patient compliance for upcoming global Phase III study. Work with CMC, Clinical Operations, Quality Assurance, Regulatory Affairs, vendors, and others, as required, to finalize and implement designs.

·Work with CMO to source the co-medication drugs required for this study.

·Manage outsourcing of labeling, packaging, storage, and distribution of manufactured drug supply and co-administered supplies to global sites.

·Translate clinical protocol into a supply forecast to determine the appropriate amounts of drug supply needed and schedule productions accordingly. Take preventive actions to avoid potential supply issues.

·Collaborate with external vendors to develop and approve specifications and user acceptance testing of IRT system. Review and request modifications when study plans change.

·Manage end to end supply chain activities including accountability and reconciliation for global trials.

·Provide timely technical review of vendor-generated documentation and collaborate with Quality to complete final review/approvals, as required.

·Collaborate with CMC, Quality, Regulatory and Clinical Operations, and others, as needed to assure joint success.

Desired Experience/Education and Personal Attributes:

·BS, MS or PharmD degree, and at least 5-7 years of clinical supply chain experience within pharma/biotech. APICS certification or coursework is desired.

·Thorough understanding of GXPs governing the manufacture of pharmaceutical drug products and conduct of routine clinical trials distribution.

·Extensive experience in clinical supply management including logistics (labeling, packaging, distribution, expiries), inventory tracking, and managing IRT systems.

·Must be knowledgeable in US, EU, and ROW clinical supply labeling requirements and the QP review/release/certification process for European clinical supplies.

·Experience with both ambient and cold chain products.

·Must be able to effectively manage multiple activities and problem-solve to achieve business needs.

·Strong communication skills, able to work independently and collaborate with key internal and external stakeholders.

·Excellent project management skills.

·Dynamic and energetic, hands on approach to challenges.

·Business travel to various company offices, suppliers, and partners as required.

Job Tags

Similar Jobs