Clinical Data Manager

Updated: February 12, 2018
Job ID: 213628
Status: 
Regular/Temporary: 
Location: Frederick, MD, United States

Come Work at HJF!

The Henry M. Jackson Foundation (HJF) is looking for a Clinical Data Manager, to support the US Army Medical Material Development Activity (USAMMDA) in the Data Management Branch at Ft. Detrick, Maryland.  HJF provides scientific, technical and programmatic support services to USAMMDA.                                                                                                      

Responsibilities:

  • Assist in implementing infrastructure for the discipline of clinical data management for FDA regulated clinical studies in human subjects
  • Write, read, implement and assist in training on clinical data management SOP’s, templates and forms
  • Review and provide documented comment on protocols prepared for FDA regulated clinical studies in human subjects by principal investigators and/or partners and prepare data management sections of regulatory and clinical documents
  • Create and review Case Report Forms, database specifications, and GCP quality control requirements
  • Mentor and advise clinical trial teams 
  • Address evolving customer needs for clinical design services, performance requirements, and procedural or application solutions   
  • Assist with implementing and executing new clinical data management procedures to plan resources and timelines for projects 
  • Perform data review, medical coding, data transfer management, Serious Adverse Event (SAE) reconciliation, database lock/unlock, data archive, and budgeting

SKILLS AND EXPERIENCE:

  • Experience in a clinical trial environment and/or performing clinical data management activities
  • Knowledge of FDA regulations and ICH standards for design, conduct, and analysis of clinical trials

MINIMUM EDUCATION: Desires a minimum of a Bachelor’s degree in Scientific or Computer discipline and at least 6 years of experience in a clinical trial environment and/or performing clinical data management.  A Master’s degree is preferred.

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status or other status protected by law.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Director of Human Resources.

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