Myriad Genetics, Inc.

Manager, Clinical Data Management

US-UT-Salt Lake City
2 weeks ago
Job ID
2017-6674
Location Details
SLC

Overview

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. 

Responsibilities

  • 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

Qualifications

  • 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.

About Myriad

Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics.  Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs.  Myriad is focused on three strategic imperatives:  maintaining leadership in an expanding hereditary cancer market, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets.  For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com.

 

Myriad is an equal opportunity employer and as such, affirms in policy and practice to recruit, hire, train and promote, in all job classifications without regard to race, color, religion, gender, age, sexual orientation, gender identity, national origin, disability status or status as a protected veteran.

 

Reasonable accommodation will be provided for qualified individuals with disabilities and disabled veterans in job application procedures. We believe that diversity lends a regional, national, and global advantage to the clients we serve. Our workforce consists of dynamic individuals, with a range of backgrounds, talents, and skills.

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