Senior Clinical Data Coder

This is a fully remote position, open to applicants in India.

📋 Description

• Lead and execute precise coding of medical terms and medications utilizing MedDRA, WHO Drug, and internal standards.

• Supervise the configuration of the coding module for assigned studies, ensuring accurate setups and workflows.

• Define, document, and manage coding conventions while ensuring their consistent application across all studies.

• Serve as the Lead Coder, coordinating coding efforts across multiple studies at the same time.

• Validate sponsor coding licenses.

• Manage coding priorities, balancing workloads across different timelines and studies.

• Contribute to the Coding section of Data Management Plans.

• Oversee and execute dictionary up-versioning and related upgrade tasks.

• Validate and test coding setups, the programming of coding reports, and perform related database checks.

• Support data review activities and address data clarifications promptly.

• Provide mentorship and guidance to junior or backup coders.

• Actively engage in process optimization, SOP creation, and the establishment of best practices in coding.

• Maintain effective communication with Data Management Leads, CRAs, and other stakeholders.

• Attend certain meetings outside of regular business hours, mainly in the evening.

⛳️ Requirements

• Bachelor’s degree or equivalent in pharmacy, life sciences, or a related field (medical/nursing background is also acceptable).

• A minimum of 5 years of relevant experience in clinical data coding within clinical trials or the pharmaceutical/CRO sector.

• Comprehensive knowledge of medical terminology and medical dictionaries (MedDRA, WHO Drug).

• Demonstrated experience in coding module setup, management of conventions, and prioritization of tasks across multiple studies.

• Experience in query management and clinical data review.

• Proven ability to manage several studies concurrently.

• Excellent written and verbal communication skills in English.

• Strong organizational and analytical capabilities with a keen attention to detail.

• Ability to lead within a global team environment, offering guidance to colleagues and ensuring deliverables are achieved.

• Good understanding of GCP and relevant Health Canada, FDA, and EMA regulations/guidelines.

• Must have legal authorization to work in India.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Ongoing learning and development opportunities.

• Attractive prospects for advancement.