Job Overview
Assist with the management of staff involved in the assembly and packaging of laboratory test kits used to collect data on clinical trials participants.
Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.
Essential Functions
• Supervise the staff involved in the assembly and shipping of visit specific kits to investigator sites
• Liaise with Inventory Control staff to ensure that appropriate supplies are available when needed
• Oversee the Quality Control process to ensure accurate shipment of clinical trials material to investigator sites
• Oversee the ongoing process of resupplying kits to investigator sites and continual monitoring and update of the auto inventory system
• Create and maintain documentation of hazardous materials shipping documentation according to applicable regulations, Responsible for the training of all staff according to the time guidelines in the clinical trials materials (CTM) training plan
• Liaise closely with the Project Management group to ensure accuracy of work orders and contents sheets pre-building, particularly at study start up
• Manage staff CVs and training records
• Archive applicable records and quality data according to standard operating procedures
• Contribute to the creation and implementation of process improvements and cost saving measures within the CTM function
• Manage staff in accordance with organization’s policies and applicable regulations
• Responsibilities include planning, assigning, and directing work
• appraising performance and guiding professional development
• rewarding and disciplining employees
• addressing employee relations issues and resolving problems
• Approve actions on human resources matters
• Provide leadership to team in absence of manager
Qualifications
• Bachelor's Degree or educational equivalent Req
• 3-4 years relevant experience including 1 year in a leadership capacity and/or equivalent combination of education, training and experience.
• In depth knowledge of CTM packaging procedures.
• Working knowledge of applicable hazardous goods shipping regulations.
• Knowledge of applicable human resources policies and procedures.
• Effective leadership skills.
• Excellent customer service skills.
• Good written and verbal communication skills.
• Good word processing skills.
• Excellent organizational skills.
• Attention to detail.
• Ability to work in a fast-paced environment.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.