Indero is hiring a Senior Clinical Data Coder for a permanent, full-time professional position in India. The role focuses on clinical data coding across multiple ongoing studies, including coding module setup, coding conventions, prioritization of deliverables, data review, and continuous improvement of coding processes.
Job Details
| Details | Information |
|---|---|
| Company | Indero |
| Position | Senior Clinical Data Coder |
| Location | India |
| Work Model | Home-based |
| Employment Type | Permanent, Full-Time |
| Experience | Minimum 5 years of relevant clinical data coding experience |
| Work Environment | Global team |
| Work Schedule | Flexible work schedule |
| Industry | Clinical Research / Pharmaceutical / CRO |
Position
Senior Clinical Data Coder
The Senior Clinical Data Coder will lead and oversee coding activities across multiple studies while ensuring compliance with regulatory requirements, industry guidelines, Indero SOPs, sponsor timelines, and expectations.
Responsibilities
- Lead and perform accurate coding of medical terms and medications using MedDRA, WHO Drug, and internal conventions.
- Oversee coding module setup for assigned studies.
- Define, document, and manage coding conventions.
- Coordinate coding activities across multiple studies as Lead Coder.
- Validate sponsor coding licenses.
- Manage coding priorities across studies and timelines.
- 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, coding reports, and related database checks.
- Support data review activities and resolve data clarifications.
- Mentor and guide junior or back-up coders.
- Contribute to process optimization, SOP development, and coding best practices.
- Maintain communication with Data Management Leads, CRAs, and other stakeholders.
Eligibility & Qualifications
Candidates should have:
- A Bachelor’s degree or equivalent in pharmacy, life sciences, or a related field.
- Medical or nursing backgrounds are also acceptable.
- Minimum 5 years of relevant experience in clinical data coding within clinical trials or the pharmaceutical/CRO environment.
- Thorough knowledge of medical terminology and medical dictionaries, including MedDRA and WHO Drug.
- Experience with coding module setup, coding convention management, and prioritization across multiple studies.
- Experience in query management and clinical data review.
- Ability to manage multiple studies concurrently.
- Excellent written and verbal English communication skills.
- Strong organizational and analytical skills with high attention to detail.
- Ability to lead within a global team environment and guide colleagues.
- Good knowledge of GCP and applicable Health Canada, FDA, and EMA regulations/guidelines.
- Legal authorization to work in India.
Required Skills
- Clinical Data Coding
- MedDRA
- WHO Drug
- Medical Terminology
- Coding Module Setup
- Coding Conventions
- Clinical Data Review
- Query Management
- Data Management Plans
- Dictionary Up-versioning
- Database Checks
- GCP
- FDA, EMA & Health Canada Guidelines
- Leadership & Mentoring
- Analytical Skills
- Attention to Detail
Work Location & Benefits
The position is home-based in India. Attendance at some meetings outside regular business hours, primarily in the evening, is required.
Eligible employees may receive:
- Flexible work schedule
- Permanent full-time employment
- Ongoing learning and development
- Advancement opportunities
About Indero
Indero is a global clinical research organization focused on dermatology and rheumatology. Formerly known as Innovaderm, the organization has more than two decades of experience in clinical research and trial delivery, with capabilities across North America, Europe, Asia Pacific, and Latin America.
Application Details
