Internship, Clinical Operations

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

The Clinical Operations Intern will be responsible to learn and assist with maintenance of the AveXis electronic Trial Master File (eTMF) which includes uploading study documentation, quality checking uploaded documents, working with the AveXis staff to ensure the eTMF is complete and inspection ready. Position will provide exposure to ICH/GCP principles related to the conduct of clinical research studies.

Responsibilities

• Create, upload, quality check documents in the Veeva vault on a daily basis.
• Ensure required site documentation (investigator site file documents, investigational product accountability documents, final study documents, and documents for inclusion in a regulatory filing, etc.) remains current in the eTMF during the conduct of a study.

Qualifications

• Must be authorized to work in the US
• Enrolled in a 4-year degree program.
• Ability to deal with time demands
• Must possess excellent Word, Excel and interpersonal skills
• Must have the ability to build and maintain positive relationships with management and peers
• 3.0 GPA

The level of this position will be based on the final candidate's qualifications.

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.

AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

#LI-EC1