PRIMARY OBJECTIVE OF THE POSITION:
The primary objective of the Clinical Data Manager is to coordinate and complete in-house data management activities to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting.
- A scientific background (BS degree or higher) with 3-5 years of clinical data management experience in the pharmaceutical/biotechnology industry.
- Be highly detail-oriented while still maintaining work efficiency, be able to prioritize activities and multi-task across various projects that will be at different study stages. MedDRA and WHO Drug coding proficiency is preferred.
- Previous experience with reviewing data and database validation for EDC (DSG’s eCaselink is preferred) is required.
- Knowledge of CDISC/SDTM standards is also highly desired.
- Bachelor’s degree in Statistics, Mathematics, or Computer Science or in a related field.
- Minimum of 4 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
- Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL.
- Demonstrate extensive knowledge of CDISC SDTM and ADaM data structures and controlled terminology, and FDA guidances and technical conformance guides covering the electronic submission standardized study data.
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
- Excellent communication and interpersonal skills to effectively interface with others.
- NDA submission experience is a plus.