Manager, Clinical Operations Data

Employer
AveXis Inc.
Location
Bannockburn, IL, US
Posted
Sep 07, 2018
Ref
2018-2426
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
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. 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 Operations Data to provide support to trial operations managers and medical directors and oversight to CRO partners across the AveXis clinical development programs. This team member must be highly motivated, organized, solution-oriented, and efficient; must have great computer skills and the ability to work effectively with multiple team members. This will be a fast-paced role within a ground-breaking clinical development program.

Responsibilities

  • Work with complex computerized records systems and maintain security and integrity.
  • Provide oversight for collection of data from clinical trials and strategize to support the overall growth/development of the data management offerings for the Clinical Operations department.
  • Provide oversight for CRF design, edit check specification preparation, and data management plan preparation/execution.
  • Review and approve design, data review ground rules and database design according to Standard Operating procedures and protocol.
  • Implement strategy for data cleaning and the design and programming of clinical databases.
  • Consult with other employees to solve operational or data problems.
  • Provide clerical duties such as data entry, transcription, coding, and collating searches.
  • Prioritize work in line with project management decisions.
  • Manage clinical trials through review, computerization, cleaning and auditing of clinical data and databases in compliance with standard operating procedures and regulatory agency guidelines.
  • Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines.
  • Generate data retrievals and summaries.
  • Query data inconsistencies and revise case report forms in compliance with standard operating procedures.
  • Review case report forms for completeness and consistency.


Qualifications

  • Bachelors or Masters degree.
  • 10 years' experience.
  • The incumbent must have the ability to manage multiple high level parallel tasks; work unsupervised, have effective computer skills, possess the ability to apply new techniques, and strong prioritization skills.
  • Must display effective planning and organizational skills, innovativeness, and keen attention to detail and excellent follow through.
  • The incumbent must have strong interpersonal skills.
  • Global travel a few times annually (


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.