Principal Clinical Coding Specialist

Caidya; India; Remote; INR 3,000,000 - 5,000,000; Full time

Job summary

Caidya in India (Remote) is seeking a Principal Clinical Coding Specialist to lead complex medical coding for clinical trials, ensuring GCP/ICH compliance and serving as SME for dictionary licensing. You will code and review adverse events, medical histories and medications, generate queries, mentor junior coders, update coding dictionaries, and coordinate with MSSO and sponsors to ensure data integrity.

Candidates need 10+ years’ medical coding experience in pharma/CRO and a healthcare or life

Qualifications

• Minimum of 10 years medical coding experience in pharma or CRO.
• Strong written and verbal communication skills.
• Excellent interpersonal skills and stakeholder management.
• Comprehensive knowledge of GCP/ICH guidelines.
• Proficiency in medical terminology.
• Ability to exercise judgment within defined procedures independently.
• Exceptional attention to detail and problem-solving abilities.
• SME of all systems linked to the coding process, understanding interactions.
• Good understanding of Clinical Data Management processes and regulatory requirements.

Responsibilities

• Coding and review of adverse events, medical history, medications, and other findings in trials.
• Generate and close coding queries in databases.
• Lead multiple study timelines and mentor junior coders.
• Perform up-versioning of coding dictionaries and data.
• Review third-party coding work for accuracy.
• Provide coding metrics and status reports with managers and sponsors.
• Maintain study documents and archiving.
• Engage in SOP updates and coding guideline development.
• Coordinate with MSSO and licensors for MedDRA/WhoDrug verifications.
• Attend startup activities and train new staff on coding processes.

Skills

Written communication

Verbal communication

Interpersonal skills

GCP/ICH knowledge

Medical terminology

Judgment and independence

Attention to detail

Problem solving

SME on coding processes

Regulatory requirements

Education

Healthcare or life science degree

Job description

Home/Office Based Either: Home or Office Based

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:

The specific job duties of a Principal Clinical Coding Specialist may include duties of Clinical Coding Specialist I,II , and Senior Clinical Coding Specialist and not limited to the following:

• 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
• 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

• 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.

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