Parexel has an exciting opportunity to advance your career in Clinical Research. We are looking for an Associate Lab Manager to oversee day to day lab operations in the Glendale, CA Early Phase Clinical Unit while managing the laboratory staff. This role ensures that all Clinical Operations, inclusive of Transit Laboratory, Shipping, and Pharmacy work outcomes are timely, efficient and of the highest quality to internal and external clients.

Please note: this role is 100% onsite at our Glendale, CA unit (no remote work)

Key Accountabilities:

• Drives a High-Performance Culture of continuous improvement, leadership, accountability, client focus, efficiency, and profitability within Clinical Operations
• Demands first-time-quality by establishing clear expectations for staff performance, clear delineation of accountability for tasks and processes and consistent monitoring of work product
• Authorize hiring, transfers, performance reviews, compensation increases, and terminations in conjunction with unit management
• Interface with key department heads and direct reports to discuss status of current trials, as well as significant staffing hurdles, capacity issues, and staff utilization
• Collect and analyze metrics that reflect performance of the departments and utilize these data to guide decision making toward Unit objectives
• Maintains and participates in the fiscal objectives of the unit and recognizes cost reduction opportunities
• Maintain thorough knowledge of all current study protocols
• Be available and support Clinical Operations staff on dosing and heavy procedure days, to include assistance with performing study procedures, if necessary
• Develop and support training sessions on study protocols, specialized clinical/laboratory procedures, and ICH/GCP guidelines
• Assist project teams in study preparation tasks such as input in drafting protocols/study specific manuals, ClinBase™ setup reviews and mock runs
• Participate in quality improvement initiatives
• Provides feedback on project feasibility, timelines, proposal review process and client negotiations
• Develop, implement, monitor, and support Standard Operating Procedures (SOPs), Training Curricula and work processes for Clinical Operations including global harmonization between Parexel EPCUs
• Provide support and/or consult on Quality Control, USP 797, GMP and GCP compliance, as needed
• Assist with internal and external audits
• Establish working relationships with client representatives to promote confidence and reliability around trial execution
• Assumes other duties and responsibilities, as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and is not to be considered as all inclusive

Skills:

• Ability to lead and motivate functional groups to be client focused, achieve Unit/project-specific objectives, and strive for continuous improvement
• Thorough knowledge of applicable international and local guidelines and regulations (e.g. ISO 9001, USP 797, GCP, GLP, GMP).
• Well-developed communication, managerial and other soft skills.
• Highly organized with the ability to manage multiple tasks of competing priorities.
• Self-motivated with a willingness to accept responsibility and challenges.
• Computer skills; ability to use MS Word, Excel, Power Point and Outlook
• Experience in dealing with confidential materials.
• Ability to effectively manage time, manage resources and multi-task.
• Ability to work a flexible schedule according to business needs

Knowledge and Experience:

• BS/MS in a related science, BSN, RN or MBA is preferred.
• 2+ years Laboratory Experience Required (preferably in a clinical research setting).
• Experience following lab protocols
• 1-2 years management experience
• Knowledge of FDA regulated drug development process, USP 797, GCP, GLP and GMP is preferred.

Benefits: this role is eligible for an annual bonus, benefits (dental, vision, medical) all available day one of work

This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.