INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development. From our early days as an academic CNS research organization in the 1980s, to the formation of INC in 1998, to where we are today, we’ve continued to improve what we do.
Post : Clinical Coder III (India) - (16005615)
Job Description
•Responsible for coding 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.
•Researches and resolves coding-related questions. Creates queries and/or notifies relevant parties as to coding discrepancies.
•Participates in the preparation for audit meetings and bid defense meetings.
•Attends QuickStart Camp and identifies coding requirements for sponsors.
•Develops project-specific coding guidelines incorporating best coding practices and sponsor-specific guidelines.
•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.
•Participates in ongoing review of auto-coded and interactively coded clinical and/or safety data for accuracy and overall consistency.
•Collaborates with Lead Data Manager/Drug Safety Manager to track and resolve outstanding coding queries/considerations.
•Generates study-specific clinical coding reports (data and/or safety) on a regular basis to facilitate an ongoing review of the coding.
•Obtains sign-off and approval of the clinical coding report from the sponsor according to study timelines.
•Shares coding expertise in meetings with all relevant parties including the sponsor, and as required.
•Attends team and sponsor meetings as the Clinical Coding representative.
•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.
Candidate Profile :
•Bachelor Degree in Life Science or Registered Nurse/Pharmacist.
•Experience in assigning MedDRA, WHO Drug, and ATC codes to clinical/safety data.
•Knowledge of coding best practices and philosophy such as MedDRA's Points to Consider
• Strong organizational, presentation,documentation, analytical, oral/ written (English), and interpersonal skills with strong judgment and tactful discretion appropriate to a professional medical setting.
• Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment.
Additional Information:
Location:Gurgaon
Industry Type: Pharma
Functional Area: Clinical Coder
Last date: 10th Janyary, 2017
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