Clinical Coding Specialist

 

A Top 10 Pharmaceutical Company is in need of a Clinical Coding Specialist for their East Hanover, New Jersey location!

 

RESPONSIBILITIES:

 

- Ensure consistency of coding across and within projects with particular emphasis on adverse events.

- Contribute to and review Validation and Planning (eVAP) coding section.

- Input into User Acceptance Testing (UAT) specifically for coded term fields.

- Consult with International Clinical Team Leaders, Medical Advisors, CDMs, CDAs, ICRO Field Monitors, Investigators and Statisticians to resolve coding problems and queries.

- Manually encode medical and therapy terms not automatically encoded by the data management system.

- Generate requests for new Medical and Therapy terms and changes to existing terms, and ensure appropriate changes are made to the dictionaries as agreed.

- Develop and maintain excellent knowledge of medical and therapy terms using appropriate information tools, e.g. electronic dictionaries, internet etc.

- Provide assistance if required for Contract Research Organizations (CROs).

- Provide medical terminology glossaries for review by project CPEs for Clinical Pharmacology trials.

- Participate in initiatives to improve the coding processes and systems.

 

REQUIREMENTS:

 

- Typically 2 or more years experience in drug development, including 1 or more years in the discipline of data management.

- Understanding of clinical trial methodology, GCP and medical terminology.

- Understanding of dictionary philosophy specifically with regard to MedDRA and WHODRL.

- Good computer skills

- Attention to detail

- Good organizational and planning skills

- Good interpersonal and communication skills and the ability to operate effectively in an international environment

- Good understanding of physiology, pharmacology, clinical study objectives and the drug development process.

- Good problem solving skills.

- Ability to work as part of a team and without close supervision.

- Ability to work under pressure and meet timelines

- Education: Degree in life sciences, pharmacy, nursing (e.g. SRN in UK) or equivalent relevant experience.