Title:  Executive - Clinical Data Coder

Job Purpose

• The job holder shall be responsible for performing Clinical Data Coding activities, under the supervision of Clinical Data Coding Lead (CDCL) and/or Clinical Data Management Project Lead (CDMPL).

Key Roles and Responsibilities

• Perform clinical data coding activities across assigned projects/program.
• May perform impact analysis for Medical Coding using MedDRA, WHO Drug and/or other relevant dictionary up versioning or as applicable.
• Validates/tests the coding set up and programming of coding reports; may also test databases, edit specifications or any coding related programming activities.
• Conduct data review (including but not limited to medical data review)
• Write and resolve data inconsistencies/discrepancies.
• May perform Serious Adverse Event (SAE) reconciliation activities.
• Works in strict adherence to SOPs and other applicable standards in compliance with Sun Procedural Documents, ICH-GCP and local regulations.
• Develop and maintain good communications and working relationships with the global clinical data management team.
• Additionally, can perform Clinical Data Management Reviewer role, if trained and as assigned under the guidance of Clinical Data Management Project Lead.

Qualification, Skill and Competencies Requirements

• Preferably a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science or related discipline.
• Minimum 3 years of clinical data coding experience including working knowledge using clinical data coding tools and applications.
• Experience of leading clinical data coding effort across global clinical studies preferred.

Job Duration

 Full Time    Part time

Job Location

India

Reporting To

Clinical Data Coding Lead (CDCL)