Clinical Data Manager job in Bethesda at Technical Resources International
Technical Resources International

Job Info

---

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

Recommended Skills

• Electronic Data Capture
• Good Clinical Practices (Gcp)
• Clinical Research
• Med Dra
• Coherent Remote File System (Crfs)
• Title 21 Of The Code Of Federal Regulations

Get job alerts by email. Sign up now!

This job has expired.