Contract Role Based in Northern, NJ — Remote ok
Must have at least 10 years of assigning standard terminologies within Clinical Research, familiar with protocol and CRF designs. Adequate knowledge of ICH guidelines.
Ensures verbatim /reported terms are adequately reported and able to assign MedDRA or WHODD terms. Responsible for resolution of PT in SAE reconciliation in collaboration with PDM and PV. Post queries for relevant information. May require to put together search groupings.
Quantitative analysis ‐ Performs a coding and review coding listing from first pass coder in preparation for Study director/Clinical Team review and approval.
Qualitative analysis ‐ Ensures all relevant information is captured in clinical database and provides quality. Ability to evaluate search groupings and perform justification of definition.
Performs all duties according to company policy and regulations and guidance. Performs other duties assigned by the Director or Sr. Manager. No travel required.
- Graduate of adequate health care related course and familiarity with medical terminologies.
- Minimum of 10 years Coding experience within Clinical Research.
- Strong knowledge of ICH guideline
- Knowledge of CODING SYSTEMS, INFORM, J -review is a plus and/or other Clinical trial Systems
- Proficiency on all related regulations, GCP, and Good Clinical DM Practice
- Computer proficiency
- Expertise on use of Microsoft applications, e.g word document, power point, excel
- Strong oral and written communication skills