Contract Clinical Trials Master File Coordinator-hybrid San Diego, Ca.

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. For more information, please visit www.xencor.com. 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.

Project Summary:

   Support Clinical Trial Management teams with document processing activities, including uploading, reviewing, and indexing tasks in a Veeva-based electronic Trial Master File (eTMF).

Job Duties:

• Provide support to Clinical Trial Management teams by processing 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. These activities may occur at various stages of the clinical trials, including study start-up, maintenance, close-out, and/or archival.
• 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.

Required Education/Experience/Skills:

• 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. 

Position also requires:

Expected HOURLY Salary Range:  $24.00 - $28.00

The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience.

Xencor requires all employees to be fully vaccinated against COVID-19 as a condition of employment.  Being fully vaccinated means that at least two weeks have passed since an individual’s final dose of an authorized COVID-19 vaccine regimen.  New employees will be required to provide proof of their COVID-19 vaccination status as of their start date unless an exemption or accommodation is approved.

Americans with Disabilities Act (ADA) Statement

The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, please contact HR@xencor.com.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Equal Employment Opportunity (EEO) Statement

The Company is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender or gender identity, national origin, disability status, protected veteran status or any other characteristic protected by state or federal law.