Maha Devan

Data Operations Coordinator (DOC) for one or two global studies with fewer than 10 operations staff. Manage delivery of projects through full data management study life-cycle. Perform comprehensive quality control procedures. Independently bring project solutions to the CDM team. Solve issues through using the global issue escalation/communication plan. Develop and maintain good communications and working relationships with CDM team.

Participate in study meetings with clients to discuss monthly data cleaning activities, improvement in data validation programs/manual data review guidelines. Review CRF / e-CRF data for completeness, accuracy and consistency via computerized edits and manual data checks. Perform 3rd Party reconciliation activities according to SOPs and work procedures under supervision of study lead. Assist in Freeze and/or Lock of eCRFs within the Electronic Data capture System.

Develop or assist with creation of Data handling/Clinical Review Guidelines Develop or assist with creation of Completion Guidelines (CGs). Independently prepare database test cases with the validation of edit check programs. Conduct UAT testing of edit checks and dynamic checks. Independently and accurately generate data queries to resolve data discrepancies. Appropriately address responses to data queries and accurately update the clinical data as necessary.