Clinical Data Manager

Salary depends on experience
Posted on 03/21/18
5 - 7 years experience
Salary depends on experience
Posted on 03/21/18

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.

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