A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Clinical Coding Specialist
Job Description
Provide timely and professional ongoing management of clinical trial coding data, Phases I to IV, by preparing coding module for validation plans. Manually code medical and therapy terms not encoded automatically, in a consistent manner across all trials and within projects, with special attention to adverse events. Review Adverse Events, Concomitant Medication and Medical History glossaries in order that databases can be declared clean and locked according to strict quality standards.
1. Ensure consistency of coding across and within projects with particular emphasis on adverse events.
2. Contribute to and review Validation and Planning (eVAP) coding section.
3. Input into User Acceptance Testing (UAT) specifically for coded term fields.
4. Consult with International Clinical Team Leaders, Medical Advisors, CDMs, CDAs, ICRO Field Monitors, Investigators and Statisticians to resolve coding problems and queries.
5. Manually encode medical and therapy terms not automatically encoded by the data manage-ment system.
6. Generate requests for new Medical and Therapy terms and changes to existing terms, and ensure appropriate changes are made to the dictionaries as agreed.
7. Develop and maintain excellent knowledge of medical and therapy terms using appropriate information tools, e.g. electronic dictionaries, internet etc.
8. Provide assistance if required for Contract Research Organisations (CROs).
9. Provide medical terminology glossaries for review by project team members when required.
10. Participate in initiatives to improve the coding processes and systems.
Candidate Profile
Degree in life sciences, pharmacy, nursing or equivalent relevant experience. Fluent in written and spoken English.
1. Typically 2 or more years experience in drug development, including 1 or more years in the discipline of data management
2. Understanding of clinical trial methodology, GCP and medical terminology
3. Understanding of coding principles and dictionary philosophy specifically with regard to MedDRA and WHODRL.
4. Good computer skills
5. Attention to detail
6. Good organisational and planning skills
7. Good interpersonal and communication skills and the ability to operate effectively in an international environment
8. Good understanding of physiology, pharmacology, clinical study objectives and the drug development process.
9. Good problem solving skills.
10. Ability to collaborate and work as part of a team and without close supervision.
11. Ability to work under pressure and meet timelines.
Additional Information:
Experience: 1-2 Years
Location: Hyderabad, India
Industry Type: Pharma/ Biotech/Clinical Research
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 158447BR
End Date: 28th February, 2015
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