Manager, Clinical Trial 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.

AveXis is seeking a Manager, Clinical Trial Operations that will be responsible for the overall management and oversight of contracted clinical trials and clinical research. The manager will be a key contributor to develop studies and create standards and guidelines for clinical research services and programs ensuring adherence to standard operating procedures, good clinical practice/ICH, FDA-EMA regulations. Relying on extensive experience and judgment to plan and accomplish goals.

Responsibilities

• Assume overall responsibility for the preparation of protocols and Case Report Forms, finalization of monitoring and data management options, ethics committee approval, development of recruitment strategies to increase patient randomization into clinical trials, the provision of clinical trial materials, and management of these trials.
• Ensure projects are in compliance with GCP-ICH guidelines, Company and/or CRO SOPs and any local applicable regulations; liaise with internal department managers and/or external CRO team members as necessary (i.e., data management, quality, clinical supplies, CRO project manager).
• Coordinate the smooth monitoring of all trials by identifying and managing qualified staff, establishing audit procedures and ensuring that cleaned data is entered into the database in a timely fashion.
• Participate on global clinical research teams ensuring that colleagues and leadership are updated on all relevant issues.
• Ensure the smooth running of the clinical operations by developing systems to track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management (may be internal or via external CRO system).
• Have responsibility for the financial management of the clinical development program including budget planning, resource allocation and preparation of at least quarterly reports for leadership/executive management.
• Coaching/training of CRAs in various aspects of specific clinical trials that are relevant to particular project issues.
• Review, assess and assure completion of training by CRAs and other clinical staff with topics that include: principles and practices of clinical project management, team communication, applicable systems and IT training.
• Contribute to protocol development; oversee CRF writing, adverse event reporting, work closely with Medical lead(s) for proper safety reporting and ensure accurate budget control processes and reporting for LT.
• Development of project documentation (ie., Synopsis, Protocols, Monitoring plans, Essential document templates).
• Training investigators and/or site staff as necessary.
• Reviewing clinical monitoring reports to assess protocol adherence.
• Administration and oversight of study budgets with CRO(s).
• Management of third-party vendors for clinical services and/or contract CRAs.
• Developing, overseeing and management of project timelines.
• Ensuring operational processes are defined toward quality project deliverables.
• Contribute to development of and maintain detailed clinical operations project plans.
• Oversee the maintenance of the project Trial Master File via CRO.
• Manage projects in accordance with the contract, proactively recognizing any changes in scope and collaborating with senior management to ensure timely completion of change orders.
• Effectively manage project budgets to ensure financial targets are met through regular reviews of indirect costs and project resources and by collaborating with Finance to ensure accurate revenue recognition.
• Monitor metrics to ensure quality and performance standards are met by all assigned project staff.
• Oversee and track progress of site identification, start-up, monitoring, and study close-out activities, including managing third-party vendors and/ or contract CRAs.
• Assist in development of key operational processes, internal training and communications on processes as required.
• Manage projects in a timely manner, in compliance with GCP-ICH guidelines, Company and/or CRO SOPs and any local applicable regulations; liaise with internal department managers and/or external CRO team members as necessary (i.e., data management, quality, clinical supplies, CRO project manager).
• Participate in process improvement initiatives as requested.

Qualifications

• Bachelor's Degree; Masters preferred.
• 5+ years Clinical Research Project Management of trials.
• Pediatric, CNS or Oncology experience highly preferred.
• Experience with CTMS and data systems (ie, IMPACT, Medidata RAVE, GRANTS MGR).
• CRO experience highly preferred.
• Excellent analytical, verbal, and written presentation skills with a working knowledge of Microsoft Office applications including Word, Excel, Access, PowerPoint, and Visio.
• Able to work at a fast pace and manage multiple complex projects.

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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