Vacancy for Clinical Data Coder I @ Parexel
Job Location: Hyderabad, Telangana, India
Essential Function
The role of the Clinical Data Coder I (CDC I) is to perform assigned tasks or activities in clinical data management coding. Activities may include user acceptance testing (UAT), coding, data validation, generation and integration of queries, and running of reports under supervision of senior coder team members and/or line manager. Under direct supervision begins to learn the Principal CDC role.
All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instruction/Guidelines, ICH-GCP and/or other international regulatory requirements.
Relationships
Reports To
Associate Manager or Manager
Directly Supervises N/A
Provides Work Directions to Project Team members as appropriate
Works Closely with All project team members, Quality Management Group (QMG) and Information Services (IT).
External Relationships Sponsors, External or 3rd party Vendors, Auditors and Regulators
Accountabilities:
• Demonstrates competence while performing activities including:
Coding
May include User Acceptance Testing
Data validation and cleaning associated to verbatim requiring coding
Generation and integration of data queries
Coding data reconciliation tasks
• Support site monitoring personnel to retrieve coding data as required
• Provide work status updates regularly to direct supervisor
• Other assigned responsibilities as needed
Qualifications
Skills
• Good interpersonal, verbal and written communication skills
• Awareness of all relevant regulations, including ICH-GCP, 21 CFR 11
• Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODrug)
• Ability to work in team environment
• Good analytical skills and attention to detail
• Effective time management to meet daily metrics or team objectives, completion of assigned tasks in a timely manner
Education
• Bachelor’s degree and / or other medical qualification or relevant Coding or Data Management experience
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