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:

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

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.

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