PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Clinical Data Coder I
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.
– 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.
• Demonstrates competence while performing activities including:
– 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.
• 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
• 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
• Previous relevant coding, data management work experience required; clinical and/ or research experience required.
Location: Hyderabad, Telangana
Industry Type: Pharma/ Biotech/Clinical Research