▪ Serve as Data Operations Coordinator (DOC) for one or two global studies with fewer than 10 operations staff (excludes DE), or serve in a leadership role to a specific DM Task. ▪ Manage delivery of projects through full data management study life-cycle (with minimal guidance). ▪ With guidance from DTL or Manager, manage project timelines and quality; determine resource needs; identify out-of-scope work. ▪ Perform review, writing and resolving data clarifications. ▪ Perform comprehensive quality control procedures. ▪ Independently bring project solutions to the CDM team. ▪ Solve issues through using the global issue escalation/communication plan. ▪ Consult with Standards Group for process issues; communicate ideas for process improvement. ▪ Assist in developing and implementing new technology. ▪ Understand and comply with core operating procedures and working instructions. ▪ Develop and maintain good communications and working relationships with CDM team. ▪ Interact with CDM team members to negotiate timelines and responsibilities.

•Perform advanced aspects of the data cleaning process, with a high degree of accuracy and in accordance with GCPs and SOPs/WPDs•Key responsibilities are to perform initial review of data discrepancies and database updates, data listing reviews, reconciliation of Serious Adverse Events and third party vendor data.

▪ Independently and accurately, review Case Report Form data for completeness, accuracy and consistency in accordance with all applicable procedures.▪ Accurately and consistently, apply data handling conventions to Case Report Forms as necessary in accordance with all applicable procedures.▪ Assist with the validation of edit check programs. Assist with the development, review and the update of relevant Data Management Study Specific Procedures.▪ Accurately perform Serious Adverse Event reconciliation and external data reconciliation in accordance with all applicable procedures.▪ Assume study lead role when applicable. Represent Data Management at internal / external meetings as appropriate. Effectively mentor less experienced staff, this may include assisting and guiding new personnel during their initial training period.▪ Perform Quality Reviews and appropriately address all issues.▪ Identify and appropriately address data discrepancies in the Clinical data via computerized edits and manual checks/listings.