Clinical Supply Specialist

GENERAL SUMMARY:  

The Clinical Supply Specialist (CSS) will report directly to the Sr. Manager, Clinical Supply Chain and will manage clinical trial materials for Phase 1 and 2 clinical trials (with minimum supervision), as outlined in the Responsibilities section. Cross-functionally, CSS will mostly interact with Quality, Clinical Operations, and Manufacturing teams. CSS will be working hybrid and reports onsite as needed. 

RESPONSIBILITIES: 

Management: 60% of TIME  

• Management of Phase 1 and 2 clinical trial materials planning and execution. 

• Accountable for communication, support, and issue resolution for site-facing drug supply management processes and on-site drug supply issues. 

• Collaborate with Clinical Operations to generate, maintain and circulate regular supply forecast and drug consumption reports. 

• CMO Management. Plan and coordinate clinical supply activities including labeling, packaging, distribution of clinical trial supplies, randomization, and drug accountability systems control. 

• Participate in supply chain business process development project. 

• Drive continuous operational performance improvement efforts. 

• Ensure compliance with Good Manufacturing Practices and applicable state and federal regulatory authorities. 

Routine Work: 40% of TIME  

• Monitor inventory levels at the depot and escalate to Supply Chain management any potential issues (shortfalls, overstock, expiration dating) 

• Oversee distribution activities to clinical sites. Review of clinical supply requests, placing ancillary supply orders, and communicating IP.  

• Generate and maintain various clinical supply inventory reports. 

• Arrange shipping of bulk clinical supply and ancillary supplies to Contract Manufacturing Organization (CMO) or depot. 

• Assist in filing CMC related documentation in eTMF. 

• Perform other duties as assigned. 

QUALIFICATIONS:  

Education:  

• Bachelor’s degree in supply chain or health care/biotech related fields   

Experience:  

• 5+ years of experience overall (in the pharmaceutical Industry) with 2+ years being in clinical or commercial supply chain management or clinical operations in Life Science or similar industry. 

• Requires working knowledge of cGMP, cGLP,  and regulations applicable to the FDA and comparable international regulatory agencies. 

Skills:  

• Demonstrated ability to work accurately, meet timelines and handle multiple priorities 

• Excellent interpersonal, verbal, and written communication skills. Able to work efficiently and effectively collaborating with colleagues and SC vendors. 

• Problem solving & adaptability. Strong attention to detail 

• Self-driven. Proven ability and desire to learn. 

• Able to perform well in a fast-paced and challenging environment. 

• Basic understanding of logistics management. 

• Proficient in Microsoft Applications (Word, Excel, PowerPoint, Projects, etc.) 
• Experience in import/export of clinical supplies or knowledge in applicable area.

Compensation Range: $109,000/year - $141,000/year 

 Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

Last updated on Aug 21, 2024