Associate Manager of Clinical Operations

Parexel has an exciting opportunity to advance your career in Clinical Research. We are looking for an Associate Manager of Clinical Operations to oversee day to day operations in the Glendale, CA Early Phase Clinical Unit while managing both clinical and 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.

Your Activities: Driving a High-Performance Culture of continuous improvement, leadership, accountability, client focus, efficiency and profitability within Clinical Operations Ensuring first-time-quality by establishing clear expectations for staff performance, clear delineation of accountability for tasks and processes and consistent monitoring of work product Authorizing hiring, transfers, performance reviews, compensation increases, and terminations in conjunction with unit management Interfacing with key department heads and direct reports to discuss status of current trials, as well as significant staffing hurdles, capacity issues, and staff utilization Collecting and analyzing metrics that reflect performance of the departments and utilize these data to guide decision making toward Unit objectives Maintaining and participating in the fiscal objectives of the unit and recognizes cost reduction opportunities Maintaining thorough knowledge of all current study protocols Supporting Clinical Operations staff on dosing and heavy procedure days, to include assistance with performing study procedures, if necessary Developing and delivering training sessions on study protocols, specialized clinical/laboratory procedures, and ICH/GCP guidelines Introducing new technologies and equipment for efficient operations Assisting project teams in study preparation tasks such as input in drafting protocols/study specific manuals, ClinBase™ setup reviews and mock runs Participating in quality improvement initiatives Providing feedback on project feasibility, timelines, proposal review process and client negotiations Developing, implementing, monitoring, and supporting Standard Operating Procedures (SOPs), Training Curricula and work processes for Clinical Operations including global harmonization between Parexel EPCUs Providing support and/or consult on Quality Control, USP 797, GMP and GCP compliance, as needed Assisting with internal and external audits Establishing working relationships with client representatives to promote confidence and reliability around trial execution Other duties as assigned QualificationsYour Skills: Ability to lead and motivate functional groups to be client focused, achieve Unit/project-specific objectives, and strive for continuous improvement 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 Your Profile: 3+ years of clinical research or pharmaceutical industry experience 1+ year(s) management experience Knowledge of FDA regulated drug development process, USP 797, GCP, GLP and GMP is preferred Experience in dealing with confidential materials Ability to travel and work a flexible schedule according to business needs Bachelor’s degree, graduate of an accredited School of Nursing (BSN preferred), or Physician training 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.

EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.