Data Management Clinical Coding Specialist

SUMMARY: Utilize standard and/or sponsor custom dictionaries to code Adverse Events, Medical and Surgical Histories, Medications and any other sponsor requested medical terminology required for projects. Ensure coding guidelines and company SOP’s are adhered to and dictionary versions / updates are maintained as appropriate for the project.

Tasks may include but are not limited to:

• As a priority, perform clinical coding of study data for multiple projects.
• Work closely with study teams and sponsors to establish coding procedures, implement applicable dictionaries and coding guidelines for projects as documented within the Data Management Plan.
• Generate coding consistency reports for internal Medical Monitor / peer review and for sponsor review at periodic time points specified for the project.
• Coordinate dictionary implementation and version updates for projects as applicable.
• Provide leadership/mentorship to support junior staff performing coding activities.
• Attend sponsor and team meeting as necessary.
• Provide regular updates to management regarding coding deliverables, metrics, coding issues, etc. as necessary.
• Ensure clinical coding operations are conducted according to WCT SOP’s.
• Other Data Management tasks as required.

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

OTHER SKILLS AND ABILITIES:

• Must be computer literate and numerate with a willingness to adapt to various computer systems. It is essential that the job holder works with close attention to detail and to be questioning about the validity of the data being entered.
• Excellent time management and man management skills.
• Experience within Data Management and coding of study data terminology.

REQUIREMENTS:

• Educated to degree level (preferably Life Science), Nursing qualification, or relevant industry experience
• Trained/experienced in coding with industry standard dictionaries (e.g., MedDRA, WHO-DD)