Sr. Clinical Data Manager, Jersey City, NJ 07311

1.Protocol review - ability to read and interpret components of Protocol that affect DM
2.Provide input into CRF design and CRF completion instructions
3.Define data entry conventions
4.Define edit checks for data cleaning
5.Identify discrepancies in database via review autoqueries and via data listings, etc.
6.Generate queries for data discrepancies to sites for resolution
7.Review and determine appropriate action for query responses (sufficient to close, needs re-query, escalation to DM study lead for discussion with CRA or Study Team)
8.Perform coding of Adverse Events, Concomitant Medications, etc. in MedDRA and WHODRUG
9.Participate in project meetings when appropriate
10.Interaction with cross-functional team members and ensure to share information with DM team (especially DM Lead for study).
11.Experience leading studies from a DM perspective, preferably from Study Start-Up to Database Lock
12.Liaise with CRO providers, to ensure that projects are completed on time and according to standards
13.Train Data Management staff as appropriate.

TO APPLY: Please email your resume to gmauk@greenkeyllc.com immediately for consideration.