The Clinical Coding Lead is a member of the Clinical Data Management team, reporting to the Head of Clinical Data Management. The individual will provide leadership in the planning and delivery of clinical coding deliverables to time, cost, and quality. Interface between the clinical project teams and Data Management Center to ensure seamless delivery of project clinical coding components.
Minimum Requirement-Education and Experience
- Serves as the expert of clinical coding dictionaries and clinical coding process.
- Responsible for the strategy, planning and overseeing of outsourced clinical coding activities by ensuring accuracy, consistency and high quality of coded data across all therapeutic areas.
- Responsible for ensuring clinical coding activities are in adherence with Clinical Data Management best practices.
- Assist with developing and implementing departmental processes and trainings as it relates to clinical coding.
- Liaise with clinical project team and Data Management Center to provide resolution to issue escalations.
- Assist Data Management Center and Patient Safety with SAE reconciliation activities.
- Provide input into the CRF development process as needed.
- Liaise with application administrations regarding the installation of dictionary upgrades to ensure appropriate dictionary versions are utilized.
- Responsible for submitting change requests to external dictionary maintenance organizations.
- Additional activities as assigned by the Head of Clinical Data Management.
- Education: University degree in science related field; medical credentials preferred or equivalent experience.
- Minimum of 5 years coding using MedDRA and WHO Drug Dictionary and/or Clinical Data Management experience in the Biotech/Pharma/CRO industry.
- Demonstrated comprehensive knowledge and experience of most aspects of Data Management
- Comprehensive knowledge of clinical and pharmaceutical drug development process and associated GCP.
- Comprehensive knowledge or regulatory requirements as they relate to Data Management and Clinical Coding activities.
- EDC experience strongly preferred.
MedImmune - 14 months ago
MedImmune works to boost the immune systems of babies and grown-ups. Its flagship biotech product, Synagis, prevents respiratory syncytial...