Manager, Clinical Data Management

Myriad Genetics Inc.
Job Location
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Salt Lake City, UT 84108
100000-116000 / Yearly Salary
Job Description

The Manager, Clinical Data Management will work under the supervision of the Group Manager of Clinical Operations and directly collaborate with Biostatistics. This individual will be responsible for running all data management processes on clinical trials conducted by the MGI Clinical Development team.

  • Participate on multidisciplinary project teams as the clinical data management representative
  • Provide input in the drafting of protocols, forms and data collection processes
  • Generate and maintain data management-related documentation including case report forms, data management plans and edit specifications
  • Lead outside vendor collaboration on transmittal of study specific data
  • Develop and perform user acceptance testing of clinical databases
  • Provide study-specific training on the electronic data capture system to internal and external personnel
  • Develop and run data query systems, when applicable
  • Perform ongoing data review and specific reports or listings as required by Statistical Analysis Plan
  • Work with IT department to ensure successful integration of clinical study data into company systems and to properly extract information from company databases
  • Develop and promote consistent data management standards through creation of DM SOPs, study guidelines, and other departmental work processes
  • Supervise clinical data manager staff

  • Minimum of 5 years of data management experience in a pharmaceutical/medical device/CRO setting is required
  • Bachelor's degree or equivalent in a relevant scientific discipline including life and health sciences
  • Experience with electronic data capture systems, preferably OpenClinica
  • Knowledge of clinical study and data management processes from study design to data archival
  • Programming experience with SAS, SQL, XML and/or JAVA
  • Ability to learn, create and maintain a working knowledge of regulatory guidelines, Good Clinical Practices and Standard Operating Procedures
  • Excellent verbal and written communication skills
  • Experience with relational database management systems
  • Ability to work in a team environment with clinical monitors, biostatisticians and medical writers
  • Oncology therapeutic area experience is preferred

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit; talk; or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop; kneel; or crouch The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision and depth perception.

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