**General Description:**
Under the supervision of the direct manager or team lead, the Specialist of Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and distribution for clinical trials. With the guidance of the manager or team lead, actively develops and oversees supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste. With guidance, may participates on teams to develop and implement process improvements to build the organization for the future.
**Essential Functions of the Job:**
+ Work with team lead or manager to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines.
+ Collaborate and liaise with internal (e.g. Clinical Operations, Regulatory, Quality, CMC) and external stakeholders (e.g. CMOs, IRT vendors) appropriately.
+ With guidance, outline supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans.
+ Work with team lead or manager to create supply and inventory plans and develop production schedules for clinical trial materials.
+ Monitor schedule adherence of production schedules and make course corrections if needed.
+ Work with label management team to ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s).
+ Assist with comparator sourcing team to conduct developed comparator sourcing strategies/activities.
+ Support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply activities in system.
+ Coordinate and track bulk shipments to CMOs, depots, and vendors. Maintain and track import licenses.
+ Participate in performing UAT acceptance testing for IRT systems
+ Supports IRT related activities to ensure adequate supply for clinical trials
+ Additional responsibilities as required
**Supervisory Responsibilities:**
+ N/A
**Computer Skills:**
+ Proficient in Microsoft Word, Excel, and Outlook
**Other Qualifications:**
+ Good analytical, communication and interpersonal skills.
+ Good organizational and effective time management skills.
+ Good problem-solving and risk management skills.
+ Good at Microsoft Office Tools
**Education Required:**
+ Bachelor's degree or above in Medicine/science related, or supply chain/management/operation related, or equivalent combination of education, training and experience.
+ 2+ years progressive experience in Supply Chain preferably within the biotech, pharmaceutical, CRO, industry.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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