This job is closed
We regret to inform you that the job you were interested in has been closed. Although this specific position is no longer available, we encourage you to continue exploring other opportunities on our job board.
About the position
Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. We have an excellent opportunity for a Contract Clinical Trials Master File Coordinator to join our team on a temporary assignment. This position is hybrid position with 2 days onsite in our San Diego office.
Responsibilities
- Support Clinical Trial Management teams with document processing activities, including uploading, reviewing, and indexing tasks in a Veeva-based electronic Trial Master File (eTMF).
- Process documents in the electronic Trial Master File (eTMF) according to Xencor Standard Operating Procedures (SOPs), Work Instructions (WIs), and trial-specific processes such as the TMF Plan and TMF Index.
- Perform TMF-related activities, including uploading, reviewing, and indexing documents for multiple clinical trial teams at various stages of the clinical trials.
- Conduct reviews of documents uploaded by cross-functional team members and CRO counterparts, assessing the accuracy and completeness of each document.
- Utilize the eTMF system, spreadsheets, and reports to track document quality issues for remediation and follow-up.
- Escalate TMF findings to Xencor leadership as appropriate.
- Attend TMF-related meetings as necessary.
Requirements
- High school diploma/GED and at least 18 months relevant experience in clinical trials research.
- Prior experience working in a small company in the biotech or pharmaceutical industry preferred.
- Working knowledge of Trial Master Files, ICH Guidelines for Good Clinical Practice, Good Documentation Practices, and the TMF Reference Model.
- Good organization skills and strong attention to detail.
- Computer skills including proficiency in use of Microsoft Outlook, Word, and Excel.
- Ability to establish and maintain effective working relationships with coworkers, managers, and vendors.
