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CTM Manager

IQVIA Holdings Inc.

Atlanta, Georgia

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
Manage staff involved in the assembly and packaging of laboratory test kits used to collect data on clinical trials participants. Ensure that kits and ancillary materials are shipped according to clients' specifications and according to budget.
Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.
Essential Functions
• Manage 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 effective preparation and implementation of start-up processes for new protocols
• 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
• Maintain high level of awareness of safety procedures in all personnel operating in CTM
Qualifications
• Bachelor's Degree or educational equivalent Req
• 5-6 years relevant experience including 2 years experience 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.
• In depth knowledge of applicable human resources policies and procedures.
• Excellent 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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

Job posted: 2021-04-22

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