Job Description

Job Title: Senior Clinical Coding Specialist

Job Location: India (Remote)

Job Overview:

Perform 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 Senior Clinical Coding Specialist may include duties of Clinical Coding Specialist I and II and not limited to the following:

• Responsible for providing technical, procedural, and subject matter leadership across multiple projects assigned to the Clinical Coding team ensuring that team members deliver in accordance with SOPs, best practices, and agreed timelines.
• Assign codes to unambiguous reported terms according to agreed coding guidelines for a given project
• Generate coding related queries and Query management in Databases
• Communicate issues that require sponsor decision, including proposal for a solution
• Ensure consistent code assignment within a project by reviewing coding and re-assignment of terms, if necessary.
• Perform up-versioning of medical coding dictionaries and clinical trial data.
• Provide independent review of data coded by third parties, if needed.
• Responsible for completeness, timely delivery, and quality of clinical data
• Provide support to other departments concerning dictionary use and code assignment
• Create and review Coding Guidelines/conventions including SOP revision as needed.
• Provide input to protocol writing, 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.
• Continuous improvement of departmental processes and procedures to ensure DM is consistently maximizing efficiencies, leveraging technology, and incorporating innovation to optimize delivery
• 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
• Assist in training new staff.
• 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 relationship and communication
• Other duties as assigned

Supervisory Responsibilities:

No supervisory responsibilities.

Job Requirements:

Education

• Bachelor’s degree or equivalent in pharmacy, nursing, or science field preferred

Experience

• Minimum of 7 years’ professional experience in the pharmaceutical industry, clinical research or at a CRO
• Clinical Research industry experience in Data Management or Clinical Coding required.

Skills/Competencies

• Extensive experience in clinical coding of medical verbatim terms collected in clinical studies across different therapeutic areas.
• Expert knowledge of MedDRA, WHODrug Global dictionaries and clinical coding best practices.
• Proficiency in medical terminology as well as body systems/anatomy, physiology, and concepts of disease
• Comprehensive knowledge of GCP/ICH guidelines
• Able to exercise judgment within defined procedures and practices and to determine appropriate action independently
• Good overview of all systems linked to the coding process, and understanding of their interactions and dependencies
• Good understanding of Clinical Data Management process
• Extensive experience in using Clinical Coding software applications in combination with EDC systems.
• Good level of English (verbal and written)
• Strong problem-solving abilities (technical, interpersonal, and decision making)

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 – effective proactive participant as a team member.

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