Sr Clin Trial Mtls Tech

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. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Job Overview
Coordinate and train 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
• Coordinate the workload of staff involved in the production of visit-specific kits and staff involved in the assembly of ancillary material, including shippers and appropriate documentation.
• Oversee QC monitoring of all CTM supplies pre-shipment to Investigator Sites.
• Monitor the performance output of CTM Technicians and Associates.
• Train new personnel and provide refresher training as required.
• Monitor inventory requirements on a shift by shift basis, reporting on stock status and maintain a minimal operating stock level as required.
• Ensure accuracy of outgoing and incoming shipment documentation (pre-prints, consignment notes, address labels).
• Ensure that all materials allow return infectious shipments to comply with the IATA dangerous goods regulations.
• Monitor work orders daily to ensure priority shipments meet with client deadlines..
• Liaise with Project Services to monitor and produce metrics and graphs showing capacity predictions for up to three months in advance
• Produce metrics and graphs showing kits, ancillaries, etc. shipped out monthly.
• Investigate and respond to any IIRs/FERs for the department.
• Liaise with Project Management and Investigator Services groups to establish shipping priorities.
• Ensure that all paperwork generated by photocopying is done in a quality manner to provide a professional appearance e.g., Investigator manuals, pregnancy kits and instructions, frozen acknowledgement forms, QC record sheets.
• Ensure that the final packaging and presentation of VSK’s prior to dispatch appears visually professional, and that upon arrival at an investigator site the packaging integrity remains neat, tidy and intact.
• Ensure shipments stored in warehouse awaiting shipping approval are dispatched on request by Study Project Manager.
• Deputise for the CTM Team Leader as required.

Qualifications
• High School Diploma or equivalent  Req
• 3 years relevant experience Req Or
• Equivalent combination of education, training and experience Req
• Attention to detail
• Good reading ability
• Effective leadership skills
• Basic computer skills
• Excellent organizational skills
• Ability to establish and maintain effective working relationships with coworkers, managers and clients