Document Specialist, Clinical Operations

Overview

Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, Inc., a Novartis Company , is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

The Document Specialist will be responsible for managing and maintaining the AveXis electronic Trial Master File (eTMF) which includes development and maintenance of an Expected Documents List (EDL), uploading study documentation, ongoing eTMF reconciliation, quality checking uploaded documents, working with the AveXis staff to ensure the eTMF is complete and inspection ready and holding the study team accountable for missing documentation.

Responsibilities

• Participate in the development and ongoing management of processes, procedures, and trainings for AveXis use of Veeva Vault eTMF.
• Upload documents into the eTMF (both Clinical Research Organization (CRO) owned and AveXis owned eTMFs).
• Clinical documentation management and tracking, prioritizing tasks and ensuring adherence to timelines.
• Use electronic systems and tools (e.g. Veeva Vault, SharePoint, ACE, ComplianceWire).
• Maintain an audit and archive ready eTMF.
• Assist in transitioning eTMF from SharePoint (or other eTMF system, for example managed by a separate CRO vendor) to Veeva Vault system.
• Quality Check documents in the Veeva Vault eTMF on a daily basis.
• Critically reviews document content to ensure accuracy and completeness.
• Communicate any document inconsistencies (GCP or ALCOA discrepancies) to Vault uploader.
• Manage the eTMF, ensuring documents maintained in the file are appropriate and the content of those documents is accurate, complete, and consistent with processes and requirements in the Veeva Vault system.
• Collaborate with internal AveXis stakeholders to gather information necessary for execution of study Expected Document List (EDL) requirements and expected numbers.
• Critically reviews document content to ensure accuracy and completeness prior to upload into TMF.
• Communicate any document inconsistencies (GCP or ALCOA discrepancies) back to functional areas for resolution.
• Perform document upload per unique study eTMF guidelines.
• Support other projects as assigned.
• Identify and contribute to areas of best practice and process improvement.

Qualifications

• Bachelor's Degree preferred.
• 2+ years of experience working in clinical research records management department or equivalent experience and demonstrated ability to present and articulate requirements of eTMF files.
• Experience with eTMF required; experience working in Veeva Vault eTMF preferred.
• Familiarity with eTMF processes and procedures.
• Advanced skills using MS Word, MS SharePoint, Adobe Acrobat Professional, and experience with MS Excel, MS PowerPoint preferred.
• Familiarity with interpretation of applicable FDA, Canadian, EU and ICH, global documentation guidelines related to clinical trial and eTMF management.
• Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines.
• The ability to multitask, prioritize, and work under pressure in adhering to deadlines.
• Strong oral and written communication and interpersonal skills.
• Strong project management and organizational skills.
• Ability to apply knowledge to new situations.

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.