Clinical Data Coder

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

📋 Description

• Provide assistance in the coding of clinical data for ongoing clinical trials.

• Engage in clinical data management tasks to guarantee that data is collected, managed, and reported in a clear, accurate, and secure manner.

• Execute activities in compliance with regulatory requirements, industry standards, SOPs, sponsor specifications, and timelines.

• Lead and accurately code medical terminology and medications using MedDRA, WHO Drug, and internal conventions.

• Supervise the setup of coding modules for assigned studies, including configurations and workflows.

• Define, document, and oversee coding conventions and synonym lists.

• Validate sponsor coding licenses.

• Function as the Lead Coder across multiple studies.

• Manage coding priorities and workloads across various timelines and studies.

• Contribute to the Coding section of Data Management Plans.

• Oversee and execute dictionary up-versioning and upgrades.

• Validate and test coding configurations, coding reports, and database checks.

• Support data review processes and resolve data clarifications.

• Communicate effectively with Data Management Leads, CRAs, and other stakeholders.

⛳️ Requirements

• A Bachelor's degree or equivalent education in pharmacy, life sciences, or a related discipline.

• A medical or nursing qualification with 2 years of relevant experience, or an equivalent combination of education, training, and experience.

• Comprehensive knowledge of medical terminology and medical dictionaries utilized for coding, such as MedDRA and WHODD.

• Preferably, experience in clinical trials or the pharmaceutical industry.

• Familiarity and experience with query management processes.

• Capacity to work flexibly on multiple projects and proactively manage time to meet deadlines.

• Excellent written and verbal communication skills in English.

• Ability to collaborate within a global team environment.

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

• Good understanding of good clinical practices and relevant Health Canada and FDA regulations/guidelines.

• Must possess legal authorization to work in India.

• Availability for some meetings outside of regular business hours, primarily in the evening.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Continuous learning and development opportunities.

• Attractive advancement prospects.

• Home-based work arrangement.