Clinical Documentation Specialist

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.

AveXis is seeking a Clinical Documentation Specialist that will manage assigned study Trial Master Files (TMFs) and oversee TMF health by conducting quality control (QC) reviews, maintaining assigned study trackers and ensuring documents maintained in the TMF are appropriate and adherence to Standard Operating Procedures, Good Clinical Practice, Good Documentation Practices, International Council for Harmonization E6(R2), and ALCOA+ standards.

Responsibilities

• Upload documents into the TMF and Veeva systems.
• Manage assigned TMFs and oversee TMF health to ensure TMF inspection readiness in real time.
• Task prioritization and timeline adherence to support inspection readiness.
• Ensure timely resolution of documents with quality issues and appropriate issue escalation.
• Collaborates cross functionally to develop TMF related plans (e.g., Transfer and Migration Plan, TMF Plan, Expected Document List [EDL] Plan) for assigned studies.
• Ad-hoc back-up for support site monitoring:
  • Advise monitors on current GCP/GDP/ALCOA+ standards.
  • Participate in Investigator Site Folder (ISF) reconciliation.
  • Support the development of site handout of ISF GCP guidance.
  • Collaborate with monitoring team to develop and/or update monitoring specific TMF trainings.
• Generate, analyze, and circulate TMF reports and KPIs (e.g., QC Rejected Documents, TMF Health, EDL Completeness) to all study stakeholders. Use results to identify and mitigate TMF documentation risks.
• Conduct Quality Checks (QC) and review content of documents to ensure accuracy and completeness (metrics meet
• Support migration of external TMFs by transcribing data or QCing already transcribed data.
• Effectively manage use of electronic systems and tools (e.g. Veeva Vault, SharePoint, ACE, ComplianceWire, etc.).
• Collaborate with internal AveXis stakeholders to manage study specific Expected Document List (EDL) ‘Requiredness' and ‘Expected Numbers'.
• Maintain assigned study specific document tracker(s) in a timely manner by entering study specific data and reviewing for missing documents, as applicable.
• Assist with internal and external study team TMF user access for assigned studies.
• Act as primary TMF SME for assigned studies.
• Support Veeva Vault eTMF system management and maintenance as back-up Clinical Administrator.
• Update TMF training materials as needed.
• Document and track TMF trainings.
• Identify trends and process improvements.
• Learn current FDA, MHRA, EMA, PMDA and other local regulations relevant to clinical study document creation, processing, management and archival.
• Act as assigned study TMF representative at study team meetings, participate in collaborative efforts and play an important cross-functional role in TMF document retrieval, guidance, and management for assigned studies.

Qualifications

• Bachelor's degree required.
• 1+ years of experience working in a clinical research/biotech/pharma company/CRO, preferred records/document/TMF management department or 2+ years in academic research or healthcare setting.
• Exposure to TMF, preferably Veeva Vault.
• Familiarity with MS Word, MS SharePoint, Adobe Acrobat Professional, MS Excel, MS Visio, and MS PowerPoint.
• Familiarity with interpretation of applicable FDA, Canadian, EU and ICH guidelines related to clinical trial and TMF management, preferred.
• Familiarity with drug development and clinical trial operations, including other functional areas involved, preferred.
• Ability to multitask, prioritize, and work under pressure in adhering to deadlines.
• Verbal and written communication and presentation skills.
• Project management and organizational skills.
• Ability to apply knowledge to new situations.
• Strong work ethic, excellent organizational skills, strong oral and written communication skills, have a ‘can do' approach, strong problem-solving skills, and be a team player.
• Ability to maintain a high level of quality, accuracy, and attention to detail in a fast-paced environment with shifting priorities.
• Proactive, self-motivated, excel at relationship building, and able to work independently with minimal supervision.

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.

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