Job Description

Position Summary:

The Senior Coder provides Coding in both MedDRA and WHODRUG dictionaries for assigned Studies on a full time basis. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives: study specific plans and guidelines will be followed. This position will perform Coding quality reviews. Working closely with the Coding Manager to ensure priority coding tasks are performed and completed in a timely manner. Working with the Coding manager to focus the medical coders as a senior coder.

Essential functions of the job include but are not limited to:

Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency (MedDRA and WHODRUG) Support other members as a back-up and/or coding team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner Backup the Coding manager for oversight of the team. Perform quality control of Coding Provide input into Coding timelines for overall deliverables. Ensure that clinical data coding deadlines are met with quality. May assess resource needs for assigned projects, as needed. Review/feedback from all stakeholders Conduct coding dictionary upgrade UAT and maintain quality controlled documentation as needed Responsible for creating, revising, appropriate versioning and maintaining data management coding documentation. Train clinical research personnel on the study specific Coding related items as needed. Review and query coding data according to the Data Management Plan and Coding standards Run coding status and metric reporting. Assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to coding activities Trains and ensures that all data management project team members coding have been sufficiently trained. Communicate with study sponsors and project teams as needed regarding coding. Present any coding demonstrations/trainings, department/company training sessions, project meetings Perform other duties as assigned.

Qualifications

Minimum Required:

5+ years' experience within Data Management Bachelors within scientific/science background and combination of related experience

Other Required:

5+ years performing Dictionary medical coding (MedDRA and WHODrug) Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook. Able to handle a variety of data management task and oversight. Excellent organizational and communication skills Professional use of the English language; both written and oral. Basic knowledge of drug, device and/or biologic development and effective data management practices

Preferred:

Experience in a clinical, scientific or healthcare discipline. Oncology and/or Orphan Drug therapeutic experience

Skills:

Demonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomes


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