Principal Clinical Coding Specialist

Caidya; Kolkata District; Remote; INR 2,000,000 - 3,200,000; Full time

Job summary

Caidya in India (Remote) seeks a Principal Clinical Coding Specialist to perform and review medical coding of free texts from clinical trials, ensure accuracy per MedDRA, and act as SME on dictionary licensing and coding software.

You will mentor junior coders, generate coding queries, oversee data management interfaces, and stay aligned with GCP/ICH guidelines and regulatory requirements.

Qualifications

• Minimum 10 years medical coding experience in pharma CRO environments.
• Experience with MedDRA and SDGs/SMQs is preferred.
• Strong understanding of GCP/ICH guidelines and regulatory requirements.

Responsibilities

• Code and review adverse events, medical history, medications, and related findings.
• Generate and close coding queries in databases.
• Lead and mentor coding staff across multiple studies.
• Perform up-versioning of coding dictionaries and data.
• Review data management plans and CRF designs for coding implications.
• Provide coding metrics and status reports to management.

Skills

Medical coding knowledge

Communication skills

Attention to detail

Regulatory knowledge

Team leadership

Problem solving

Education

Healthcare or life science degree

Tools

MedDRA

WhoDrug

Coding software

Job description

Job Description

Job Title: Principal Clinical Coding Specialist

Job Location: India (Remote)

Job Overview

Perform and review medical coding of free texts collected in the course of a clinical trial or from other sources, taking into account, appropriate coding guidelines and to act as Subject Matter Expert on all clinical coding matters including dictionary licensing, impact of new dictionary releases, and the use of clinical coding software applications.

Job Duties and Responsibilities

• Responsible for coding and review of coded adverse events, medical history, medications, and any other pertinent findings reported within the clinical study as contractually obligated.
• Generates coding queries as needed in the databases and closes queries when resolution is achieved.
• Manages and supports all functional tasks and project deliverables from single study assignments to large programs of studies.
• Perform up-versioning of medical coding dictionaries and clinical trial data.
• Review up-versioning done by Junior team members.
• Perform independent review of data coded by third parties, if needed.
• Analytical experience in trend analysis in QC and consistency findings.
• Create and review Coding Guidelines/conventions including SOP revision as needed.
• Review and provide feedback on Data Management Plan, database setup, and CRF design process with respect to coding.
• Performing Test data creation & User Acceptance Testing, Provide Coding Metrics, Coding status reports with Lead Data Manager/Sponsor as per requirement.
• Maintaining Clinical Study Documents and archiving as appropriate
• Responsible for completeness, timely delivery, and quality of clinical data.
• Manages multiple project timelines and deliverables while leading less experienced coders.
• Perform coding listings review for consistency and quality of coded data. Mentor peers in the use of Standard MedDRA Queries (SMQs) and Standard Drug Groupings (SDGs) for optimal analysis.
• Correspond directly with MSSO and Uppsala for MedDRA and WhoDrug license verifications.
• Study startup SME (attend Kick-off meetings, quality start camp, and all study start-up-related tasks).
• Training new staff on coding process and providing managers with feedback.
• Maintains working knowledge of regulatory requirements/guidance as well as industry-leading best practices to ensure the company’s DM procedures are in line with industry expectations
• Continuous improvement of departmental processes and procedures to ensure DM is consistently maximizing efficiencies, leveraging technology, and incorporating innovation to optimize delivery.
• Attend and participate in project/company meetings including occasional off-hour calls to coincide with offices in other time zones
• Handling customer requests and developing customer relationships and communication.
• Assist coding manager with updating coding assignment spreadsheet with assigned coding projects.
• Other duties as assigned.

Supervisory Responsibilities

May provide work direction and oversight to Coding Specialist.

Job Requirements

Education

• College graduate, preferably with a healthcare or life science degree

Experience

• Minimum of 10 years medical coding experience in the pharmaceutical industry or at a CRO

Skills/Competencies

• Strong written and verbal communication skills
• Strong interpersonal skills
• Comprehensive knowledge of GCP/ICH guidelines
• Proficiency in medical terminology.
• Able to exercise judgment within defined procedures and practices and to determine appropriate action independently
• Exceptional attention to detail.
• Exceptional problem-solving skills.
• Exceptional proficiency in medical terminology as well as body systems/anatomy, physiology, and concepts of disease
• SME of all systems linked to the coding process, and understanding of their interactions and dependencies
• Good understanding of Clinical Data Management processes and the applicable regulatory requirements

Capabilities

• Strong computer skills, including Microsoft Office
• Flexibility - willing to change assignments and work focus to accommodate project demands
• Communication skills -must be able to write well and convey information in an orderly way, as well as to take responsibilities, work as part of a team as a team member and a team leader, and ask questions, if necessary.
• Ability to work under pressure -Able to handle quick turnaround times, large volumes of work.
• Team player/Team leader – effective proactive participant as a team member and team leader as needed.

The company will not accept unsolicited resumes from third-party vendors.