Clinical Data Coder II
Job Location: Hyderabad, Telangana, India
The role of the Clinical Data Coder II (CDC II) is to perform assigned tasks or activities in clinical data coding. Activities may include user acceptance testing (UAT), coding, data validation, generation and integration of queries, running of reports.
To include database set-up through to database lock on assigned projects and with minimal direction/supervision. Undertakes the Principal CDC role on designated studies.
All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instruction/Guidelines, ICH-GCP and/or other international regulatory requirements.
• Demonstrates full competence when conducting the following tasks:
§ Conduct medical coding
§ Development of database build specifications related to coding
§ Development of data validation specifications related to coding
§ Test data creation & User Acceptance Testing
§ Performing/ leading functional QC activities and testing
§ Coding validation and cleaning
§ Conduct data reconciliations
§ Database lock activities relative to coding
§ Maintaining Clinical Coding Specification documents
• Responsible for completeness, timely delivery and quality of clinical data
• Act as a single point of contact (internal expert) for specific processing task(s) on a project
• Support site monitoring personnel to retrieve coding as required
• Other assigned responsibilities as needed
• Strong interpersonal, verbal and written communication skills
• Strong technical skills including but not limited to the knowledge of Clinical Trial/Data Management/ Coding Systems, PMED, MS-Office products
• Good awareness of all relevant regulations, including ICH-GCP, 21 CFR 11
• Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODrug)
• Seeks opportunities to develop experience and knowledge in Clinical Trials and Pharmaceutical Industry
• Ability to plan tasks and complete them within the appropriate timescale and to the required quality
• Ability to work in team environment
• Good analytical skills and attention to detail
• Effective time management in order to meet team objectives
• Commitment and performs consistently high quality work
• Bachelor’s degree and / or other medical qualification or relevant Coding or Data Management experience
• Competent in written and oral English. Excellence in regional languages as needed.
Minimum Work Experience
• Must be able to demonstrate proficiency with several tasks included in data start-up through data-base lock. Previous relevant coding, data management work experience required; clinical and/ or research experience with solid understanding of clinical trials methodology and terminology required.