Description:
Fully remote

Reports to (Sr.) Mgr Clinical Supply Chain.
Candidates will, under limited supervision and in compliance with clinical regulatory requirements, partner with key stakeholders to support inspection readiness for various clinical programs and clinical studies.

Key Responsibilities:

• Inspection Readiness for clinical programs and studies
• Retrieve documents from various internal repositories and systems
• Retrieve documents from external vendors
• Create process and clinical study overviews/ storyboards and other inputs for inspection presentations
• Organize documents in Inspection Readiness trackers per program and clinical study
• Ensure all documents are logged in a consistent and traceable manner
• Support inventory reconciliation for inspection readiness
• Support document upload in eTMF and ensure document readiness for inspection

Qualifications:
Master's Degree & no Supply Chain experience
Bachelor's Degree & 2 years of Supply Chain experience or
High School Diploma/GED and 5+ years of Supply Chain experience

Technical skills:

• Experience with clinical study management
• Experience with inspection readiness processes
• Experience with document management in eTMF (Trial Master File)
• Good MS suite skills, with an emphasis on Outlook and Teams
• Experience with Quality Management Tracking Systems (QMTS)
• Smartsheet and SharePoint knowledge
• General knowledge of clinical supply chain management

Competencies:

• Accuracy and attention to detail
• Results oriented, with a strong adherence to timelines
• Accuracy and attention to detail
• Process-oriented
• Excellent communication skills (both written and verbal)
• Ability to interface effectively at all levels with international peers and customers
• Anticipate problems and recognize when to escalate issues
• Set priorities within general guidelines
• Ability to operate in a team as well as a strong matrix environment
• Analytical skills
• Quality minded

Basic Qualifications    
High school/GED + 2 years work experience OR​ Associate’s and 6 months work experience OR​ Bachelor’s

Top 3 Must Have Skill Sets:    

• Experience with clinical study management
• Experience with inspection readiness processes
• Experience with document management in eTMF (Trial Master File)
• Good MS suite skills, with an emphasis on Outlook and Teams
• Experience with Quality Management Tracking Systems (QMTS)
• Smartsheet and SharePoint knowledge
• General knowledge of clinical supply chain management

Pay Rate  between $35 - $40/hr on W2 based on experience.
 
"This posting is for Contingent Worker, not an FTE"