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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 organizations 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
Bachelors 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.
Full-Time