Summary:
The Senior Data Coding Specialist serves as a resource for the Data Management (DM) organization and/or project team regarding the coding of clinical trials data (i.e., adverse events, medical history, physical examination findings, medications) and coding dictionary issues. The Sr. Data Coding Specialist is responsible for coding and review of codes applied to clinical trial data for projects where DM is responsible for the coding of clinical data and participates in the development of Standard Operating Procedures (SOPs), Data Management Plans and clinical database validation and management tools. The Sr. Data Coding Specialist interacts with Sponsors to clarify coding guidelines and verify licenses.
Title: Senior Data Coding Specialist
Location: Kochi (onsite)
Responsibilities:
- Accurately, within project timelines and according to project guidelines, codes clinical trials data (e.g., adverse events, medical history, physical examination findings, and/or medications) and ensures completeness, accuracy, and consistency of the codes through use of data listings, computer generated reports, or on-line review.
- Develops and validates coding specifications, ad hoc listings, reports, and queries for use in the validation of coded data in the clinical database.
- Performs study specific User Acceptance Testing (UAT) of the coding module used for assigned studies.
- Performs peer reviews of coding reports and provides guidance to other Data Coding Specialists.
- Coordinate up versioning of assigned dictionaries throughout the life of a study, as needed.
- Review or provide input into the development of SOPs, Data Management Plans, and project management tools.
- Maintains a good understanding of currently used coding dictionaries and guidelines in order to effectively serve as a department resource.
- Interfaces with project teams to resolve problems and issues dealing with the coding of clinical data.
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Trains Data Coding Specialists, as well as Data Management staff, on coding dictionary structures, conventions and/or use of coding software to apply codes or run reports.
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Interact with Sponsors by gaining working knowledge of project coding specifications, receiving feedback on coding reports, promoting consistency across projects within or resolving coding questions.
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Verifies active sponsor dictionary subscriptions.Qualification:Education: Bachelor’s degree in related discipline and 4 years of related experience or HS diploma and 7 years of related experience.Experience: 2-4 years of medical coding experience in pharmaceutical and/or contract research organization.Required Skills:
- Sound evidence of medical terminology and dictionaries.
- Knowledge of clinical trials concepts.
- Proficiency with EDC Coding applications (EDC systems, preferably Medidata Rave).
- Proficient with Microsoft Office Suite.
- Excellent written and oral communication skills.
- Excellent presentation skills.
- Strong organizational, problem-solving, and analytical skills
- Ability to manage priorities and workflow.
- Versatility, flexibility, and a willingness to work within constantly changing priorities.
- Proven ability to handle multiple projects and meet deadlines.
- Strong interpersonal skills.
- Ability to deal effectively with diversity of individuals at all organizational levels.
- Commitment to excellence and high standards.
- Creative, flexible, and innovative team player.
- Ability to work independently and as a member of various teams and committees.
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Good judgement with the ability to make timely and sound decisions.