Xencor is an innovative, clinical-stage biopharmaceutical company located in the Los Angeles area (near Pasadena) and in San Diego. We use our pioneering XmAb® technology to discover and develop better biotherapeutics – antibodies and other proteins with improved function – with the goal of improving patient outcomes and quality of life, and we have an excellent opportunity for a Clinical Document Manager to join our team.
Our capabilities and the modular nature of XmAb technology allows us to quickly identify and create new platforms and drug candidates for potential development. We are developing a deep pipeline of novel drug candidates enabled by the rapid expansion of our bispecific antibody and cytokine technologies. Nine XmAb bispecific antibody programs are in clinical testing, and more are expected to start clinical testing in 2021. We also leverage our many XmAb technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen and Genentech, among others. We and our partners are advancing 18 XmAb drug candidates through clinical development, and two medicines that incorporate XmAb technology are approved for commercial marketing.
Job Duties include:
• Provide technical oversight of the Veeva Systems eTMF Vault as the primary Vault Owner. Implement configuration updates, administer the Veeva Vault eTMF application, and provide user support.
• Provide managerial oversight and mentoring for junior CRAs and CT As and those new to the company and/or trial.
• Responsible for the maintenance of the eTMF. Performs ongoing reviews of eTMF to ensure quality of the documentation files and compliance with Xencor SOPs, GCP, and ICH Guidelines.
• Develop internal processes and procedures relating to the eTMF
• Work with external organizations (e.g. CROs) that have been contracted to perform TMF activities in order to develop study-specific eTMF processes
• Develop training materials and train internal and external users in the proper use of the eTMF
• Upload, review and approve eTMF documents
• Develop reports and other tools to aid in measuring TMF completeness
• Coordinate reviews of the TMFs for inspection-readiness
• Understand assigned clinical trial protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned trials
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
• Excellent organization skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Understanding of clinical trials, drug development, Phase I through Phase III
• Computer skills including proficiency in use of Microsoft Outlook, Word, Excel, and PowerPoint
• Experience with Veeva Vault system (required)
• Experience with SmartSheet (desired)
• Solid working knowledge of GXP practices
The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.
The physical demands of the office are normally association with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Work is performed in an office environment
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