Clinical Data Manager
Technical Resources International

Job Info

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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

This job has expired.