Clinical Data Manager at Technical Resources International

Posted in Other 20 days ago.

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Location: Bethesda, Maryland





Job Description:
Responsibilities:
  • Works with cross-functional teams in designing, documenting, testing, and implementing studies in Electronic Data Capture systems. iMedidata Rave experience a plus
  • Develops study specific electronic or paper Case Report Forms (CRFs), ensuring consistency with study protocol, clinical requirement, accurate, and efficient data collection
  • Responsible for clinical database management, data verification, data cleaning, and quality assurance of multiple projects
  • Creates and maintains data management documents per SOP (e.g. Data Management Plan, Data Validation Plan, Data Entry Guidelines, Data Transfer Agreements, etc.)
  • Creates and cleans edit checks to ensure data are in accordance with Good Clinical Practices (GCP) and study protocols
  • Generates, resolves data queries and interface with study site personnel to expedite resolution of queries and to improve quality of data being collected
  • Generates and reviews clinical medical coding for accuracy, i.e. MedDRA and WHODRUG
  • Prepare reports and assist with data presentations as applicable
  • Validates clinical trial database on an ongoing basis for accuracy, completeness and consistency
  • Develops source documents, CRFs, Standard Operating Procedures (SOPs), study specific SOPs and all other documentation required for the proper conduct of a clinical trial


Job Requirements
Requirements:
  • Bachelor's degree in life sciences or health-related field
  • 2+ years of experience in data management and/or database design in clinical research setting
  • Knowledge of GMP, GCP, GLP, and 21 CFR Part 11 regulations a plus
  • Strong documentation and communication skills are required
  • Experience with Electronic Data Capture (EDC) is required, iMedidata Rave experience a plus
  • Abstract and critical thinking to work with open-ended or undefined issues
  • Strategic and cost-effective mindset, self-starter with proactive attitude



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