Clinical Data Coder-India

Indero (formerly Innovaderm); Maharashtra; Remote; INR 600,000 - 900,000; Full time

Benefits offered by this job

Flexible work schedule

Permanent full-time position

Ongoing learning and development

Job summary

Indero is seeking a Clinical Data Coder to support coding of clinical data for ongoing studies from a home-based position in India. You will lead coding activities, configure coding modules, and ensure consistency of coding conventions while adhering to regulatory guidelines and sponsor timelines.

The role requires a pharmacy/life sciences background, strong English communication, and experience with MedDRA/WHODD.

Qualifications

• Bachelor's degree in pharmacy, life sciences or related field, or equivalent combination of education and experience.
• Thorough knowledge of Medical Terminology and coding dictionaries (MedDRA, WHODD).
• Experience in clinical trials or pharmaceutical environment preferred.
• Strong query management and attention to detail.
• Ability to manage multiple projects and meet deadlines.
• Excellent written and verbal English communication.
• Ability to work in a global team environment.
• Knowledge of Good Clinical Practice and regulatory guidelines (FDA/Health Canada).

Responsibilities

• Lead and perform accurate coding of medical terms and medications using MedDRA, WHODD and internal conventions.
• Oversee the setup of the coding module for assigned studies.
• Define and manage coding conventions and synonym lists.
• Validate sponsor coding licenses.
• Coordinate coding activities across multiple studies.
• Manage coding priorities and timelines.
• Provide input to the Data Management Plans.
• Support data review activities and resolve clarifications in a timely manner.
• Maintain communication with Data Management Leads, CRAs and stakeholders.

Skills

Medical terminology

MedDRA/WHO Drug knowledge

Pharmacy or life sciences background

Clinical trials experience

Query management

English communication

Global team collaboration

Regulatory knowledge

Education

Bachelor's degree in pharmacy or life sciences

Job description

The Clinical Data Coder is primarily responsible for providing support to activities related to coding of Clinical data for ongoing clinical studies. The Clinical Data Coder will also participate in various clinical data management activities required to ensure that data captured are collected, managed and reported clearly, accurately and securely. In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Indero standard operating procedures (SOPs) while respecting Indero's commitment to sponsor's requirements and timelines.

More specifically, the Clinical Data Coder must:

• Lead and perform accurate coding of medical terms and medications using MedDRA, WHO Drug, and internal conventions.
• Oversee the setup of the coding module for assigned studies, ensuring correct configurations and workflows.
• Define, document, and manage coding conventions, synonym lists and ensure consistent application across studies.
• Validate sponsor coding licenses.
• Act as the Lead Coder, coordinating coding activities across multiple studies simultaneously.
• Manage coding priorities, balancing workload across timelines and studies.
• Provide input to the Coding section of Data Management Plans.
• Oversee and perform dictionary up-versioning and related upgrade activities.
• Validate and test coding setups, programming of coding reports, and related database checks.
• Support data review activities and resolve data clarifications in a timely manner.
• Maintain effective communication with Data Management Leads, CRAs, and other stakeholders.

Requirements

• Bachelor's degree or educational equivalence in pharmacy, life sciences or related field or medical, nursing qualification with 2 years relevant experience or equivalent combination of education, training and experience;
• Thorough knowledge of Medical Terminology and Medical Dictionaries used for coding (e.g. MedDRA, WHODD etc.);
• Experience working with clinical trials or within the pharmaceutical environment is preferred;
• Demonstrate understanding and experience in query management process;
• Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines;
• Excellent written and verbal English communication skills;
• Ability to work in a global team environment;
• Good organizational and analytical skills and high attention to detail;
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

Our company

The work environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

• Flexible work schedule
• Permanent full-time position
• Ongoing learning and development

Work location

Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required.

About Indero

A Global Clinical Leader in Dermatology and rheumatology!

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years' experience in clinical research and trial delivery. Our full-service approach - which includes everything from protocol design and patient recruitment to trial monitoring and biometrics - provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in India.