Working hours for this role: 2PM-10.30PM
Location: West Chester, OH
6 Month contract with possible conversion.
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 liaison 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 PPD 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 PPD 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) or equivalent combination of education, training, & experience.
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
• 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
Working Conditions and Environment:
• Work is performed in a production, office or home based environment with exposure to electrical equipment.
Physical Requirements:
• Frequently stationary for 4-6 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional mobility required.
• Occasional crouching, stooping, bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
• Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.