Senior Clinical Data Manager
A specialty pharmaceutical company based in New Jersey is seeking a Senior Clinical Data Manager for a 5-month renewable contract for their Research and Development team. This pharmaceutical corporation focuses on Managing Complexity and Improving Lives with the medicines they provide to meet patients' needs.
The Senior Clinical Data Manager will be responsible for: 1) Reviewing Protocols to ensure database feasibility. 2) Develop, document and perform validation of database structure, data capture screens, code lists, edit checks, reports and other functions in Electronic Data Capture (EDC). 3) Write, review and maintain eCRF completion guidelines, data management plan (DMP), data validation plan and other DM related documentation. 4) Write and review Data Management SOPs in accordance with GCP and ICH guidelines, and develop associated training and competency testing. 5) Monitor study status and provide status reports to the team.
Duration: 5-month contract (opportunity to renew)
Location: on-site in Somerset County, New Jersey
Pay Range: $55-60 per hour
- Education Requirement: a minimum of a B.S. in Mathematics/Statistics, Computer Science, Life Sciences or related field.
- Must have experience & knowledge of GCP and ICH guidelines.
- Must have a minimum 8 years of data management experience in the pharmaceutical or biotechnology industry.
- Proficient with Clinical Data Management Systems (CDMS) and experience with Electronic Data Capture (EDC) systems.
Sthree US is acting as an Employment Business in relation to this vacancy.