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Post: Sr Clinical Coder (India)
Job Description
1. Functions as the Lead Coder on multiple projects.
2. Responsible for coding of clinical and/or safety data and ensures coding consistency, uniformity, and clarity across all pertinent data. Verifies with relevant authorities that sponsors’ license requirements are met.
3. Researches and resolves coding-related questions. Creates queries and/or notifies relevant parties as to coding discrepancies. Functions as the Project Lead on coding-only studies including legacy recoding projects.
4. Participates in audits and bid defense meetings.
5. Attends QuickStart Camp and identifies coding requirements for sponsors.
6. Serves on project teams to coordinate and lead development activities for clinical coding projects. Attends meetings, participates in discussions, focuses on deliverables, and provides constructive criticism. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple taste assignments and communicates needs to supervisor to obtain needed resources.
7. Develops project-specific coding guidelines incorporating best coding practices and sponsor-specific guidelines.
8. Identifies and refers reported terms that are not able to be coded per coding guidelines to Lead Data Manager/Drug Safety Manager for further disposition.
9. Participates in ongoing review of auto-coded and interactively coded clinical/safety trial data for accuracy and overall consistency.
10. Collaborates with Lead Data Manager/Drug Safety Manager to track and resolve outstanding coding queries/considerations.
11. Generates study-specific clinical coding reports (data and/or safety) on a regular basis to maintain high-quality coding.
12. Obtains sign-off and approval of the clinical coding report from the sponsor according to study timelines.
13. Shares coding expertise in meetings with all relevant parties including sponsors, as required.
14. Serves as subject matter expert at team and departmental meetings as the Clinical Coding representative.
15. Reviews and understands study protocols and other related materials. Maintains an overall knowledge of regulatory guidelines, industry standards, and new technologies as they relate to coding requirements.
Qualifications:
Bachelor Degree in the biological sciences or related disciplines in the natural science/health care field.
Nominal, directly related data management experience or equivalent combination of education and experience.
Experience in assigning MedDRA, WHO Drug, and ATC codes to clinical/safety data. Working knowledge of ICH/Good Clinical Practices.
Ability to multitask under deadlines and work as part of a multi-disciplinary team as well as independently.
Additional Information:
Qualification: Bachelor Degree
Location: Gurgaon
"Industry Type: Pharma/ Biotech/Clinical Research
End Date: 17th March, 2015
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