Description
The Senior Clinical Data Coder is primarily responsible for leading and overseeing activities related to the coding of clinical data across multiple ongoing studies. In addition to performing accurate coding tasks, the Senior Coder takes ownership of the coding module setup, establishes conventions, and drives the prioritization of coding deliverables. This role includes leadership responsibilities and active participation in the design, oversight, and continuous improvement of coding processes. The Senior Clinical Data Coder will conduct all activities in alignment with applicable regulatory requirements, industry guidelines, and Indero SOPs, while ensuring sponsor timelines and expectations are consistently met.
Key Responsibilities
- 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 and ensure consistent application across studies.
- Act as the Lead Coder, coordinating coding activities across multiple studies simultaneously.
- Manage coding priorities, balancing workload across timelines and studies.
- Develop and maintain coding guidelines and synonym lists.
- 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.
- Provide mentorship and guidance to junior or back-up coders.
- Actively contribute to process optimization, SOP development, and best practices in coding.
- Maintain effective communication with Data Management Leads, CRAs, and other stakeholders.
Requirements
- Bachelor’s degree or equivalent in pharmacy, life sciences, or a related field (medical/nursing background also acceptable).
- Minimum of 5 years’ relevant experience in clinical data coding within clinical trials or the pharmaceutical/CRO environment.
- Thorough knowledge of medical terminology and medical dictionaries (MedDRA, WHO Drug).
- Demonstrated experience with 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 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, providing guidance to colleagues and ensuring deliverables are met.
- Good knowledge of GCP and applicable Health Canada, FDA, and EMA 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 / work schedule :
- Home-based position
- Ongoing learning and development
About Indero
A Global Clinical Leader In Dermatology & 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 Colombia
