The Laboratory Operations Manager (CLS Kitting) will utilize their expertise in central laboratory operations to oversee the execution of clinical trials kitting projects for multiple fast-paced clinical studies supporting clients engaged in cutting-edge research. This role entails close collaboration with leaders from Project Management, Logistics, Business Development, Proposals, Procurement, and Finance teams to ensure efficient resource utilization and adherence to agreed-upon timelines. The ideal candidate will possess direct experience in managing clinical trials central lab operations, along with a working knowledge of regulatory guidance and industry best practices. Additionally, they will contribute to short and long-term financial forecasting for the Kit Production team within Central Lab Services Management.

Essential functions of the job include but are not limited to: 

• Collaborate with Project Management, Logistics, Business Development, Proposals, Procurement, and Finance teams to prioritize and communicate daily activities for team members, ensuring timely kit preparation and delivery to meet client demands.
• Act as a liaison between cross-functional business groups to support task organization from project award to delivery, addressing any identified gaps that may impact scheduled study deliverables.
• Manage operational scheduling and forecasting for Kit production, coordinating with relevant teams to forecast work across all projects.
• Assist in project planning related to schedule kit production, considering factors such as kit component availability and staffing constraints.
• Work with the Financial Project Analyst to update the scheduling tool (e.g., Smartsheet) with newly awarded work and change orders, ensuring accurate billing activities.
• Coordinate change orders and scope of work amendments with Project Managers and Financial Project Analysts to identify additional support needed for lab activities.
• Establish appropriate Key Performance Indicators (KPIs) and metrics for the Kit Production teams, monitoring and reporting trends to stakeholders.
• Supervise and mentor team members to ensure efficient workflow and high-quality outputs.
• Perform other duties/projects as assigned.

Qualifications:

Minimum Required:

• Bachelor’s Degree in a related field and a minimum of 3 years of relevant experience or equivalent combination of education and experience.

Other Required:

• Experience in operational management of central lab services functions and cross-functional operational project management.
• Solid understanding of current GLP, GCP, or GCLP standards.
• Working knowledge of CAP/CLIA and ISO 9001.
• Strong oral and written communication skills.
• Understanding of operational workflow including kitting, quality control, study set-up, and deliverables.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Smartsheet.
• Ability to thrive in a highly productive work environment.
• Ability to work independently with attention to detail.
• Physical ability to lift and carry weights ranging from 1-50 lbs., may be exposed to cold freezer environments.
• Fluent English language skills in reading, writing, speaking, and comprehension.