Location: Highland Heights,KY, USA
Position Summary:
Provides support to clinical supplies operations and administrative activities in all areas of clinical supplies
lifecycle of low to moderate complexity studies.
Essential Functions:
• Coordinates, supports, and performs logistics and administrative work to support the department.
• Supports the day-to-day operations of the study drug, comparators and ancillaries management.
• Ensures all activities are executed in compliance with company good practices and client requirements.
• Completes ongoing training on new regulations concerning all clinical supplies and GxP activities.
• Participates in and supports department project teams.
• May coordinate or serve as a liason cross-functionally.
• Oversee the daily drug product/medical device receipt, ordering, storage, label printing, labeling activities, inventory management, distribution, return drug accountability and destruction
• Ensure all activities executed by client Depots comply with company SOPs, and client requirements.
• Track inventories and expiration dates of all department drug products and medical devices. Issue monthly status reports.
• Arranges purchases of additional supplies upon request.
• On going Training on new Regulations concerning GMP activities.
• Maintain Updated Client Owned Metrics Indicators Reports.
• Maintains accurate data in electronic management systems for assigned studies.
Education and Experience:
• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Technical positions may require a certificate
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at
• least 2 years).
Knowledge, Skills and Abilities:
• Intermediate English and good communication skills both written and verbal
• Solid understanding of the Clinical Supply process, such as manufacturing, handling, importing, shipping, exporting, auditing, labeling and packaging
• Strong organizational, planning and time management skills
• Planning analytical skills
• Good analytical skills and ability to work on issues of a diverse and confidential nature
• Proficient in Microsoft Office programs
• Strong customer service orientation and attention to detail aligned with high standards of quality and excellence
• Adaptive to changes and ability to handle high-pressure situations
• Ability to work in a team environment as well as work independently with moderate direct supervision
• Ability to utilize proper channels of communications to voice concerns and suggestions.
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification