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. Back up to Manager Clinical Coding and Data Management as required.
Responsibilities
Tasks may include but are not limited to:
- As a priority, provide coding support for projects including:
- Coding activities for Study start up on existing and current EDC databases
- Input into the Data Management Plan, performing User Acceptance Testing, including review of Database Specifications and CRFs
- Performing manual coding of medical and medication terms, generation and review of coding consistency reports for accuracy and submission of coding reports to 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.
- Communicate effectively with Sponsors on general and project specific coding issues, as needed.
- Ensure coding is performed and delivered consistently both internally and externally with the highest quality and timelines are met according to study requirements.
- Coordinate dictionary licence validation checks and Worldwide licence renewal process.
- Identify coding process and technology improvements, implement changes, monitor the outcome and recommend further action.
- Provide leadership/mentorship to support junior staff performing coding activities.
- Attend sponsor and team meeting as necessary.
- Maintain solid awareness of study coding budget and potential CIS/OOS issues related to coding for studies.
- Provide regular updates to management regarding coding deliverables, metrics, coding issues, etc. as necessary.
- Ensure clinical coding operations are conducted according to WCT