Senior Clinical Data Manager

About the role

The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed.

What you'll do

• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed
• Review and query clinical trial data according to the Data Management Plan

What you need

• 10–18 yrs of experience
• Clinical research
• PowerPoint
• Medical coding
• SAS
• Clinical data management
• Communication
• Any graduate

Good to have

• SOP writing
• SAP
• Reconciliation