Sr. Clinical Data Manager

Direct activity of CDM team members to complete project deliverables on schedule according to quality standards, requirements, and project budget from study start-up through archival

Serve as CTI CDM representative on project teams

Recommend alternative work processes to improve quality or speed of customer deliverables and respond to questions on CDM process, timelines, and data quality

Maintain positive working relationship with internal customers and sponsor by keeping them up-to-date about progress of projects and working with them to develop coordinated plans that meet customers’ needs

Maintain open communication with internal and external customers by contacting sponsor counterpart on agreed-upon schedule, responding to correspondence promptly and within agreed upon timeframes and choosing method of communication based on urgency and type of information being communicated

Evaluate team requests by considering factors such as efficiency, quality, budget, resources, and customer relations before committing to an action; seek out existing knowledge prior to developing new methods

Develop and maintain CDM study files; Identify all internal and sponsor CDM deliverables contracted in scope of work and establish time estimates; Specify data cleaning guidelines, conventions, Global Standard Operating Procedure (GSOP), data workflow, and other processes, which will be followed to meet sponsor requirements

Continuously evaluate timelines in relation to work completed and communicate impact on milestones to CDM management, project team members, and sponsor

Maintain consistent, manageable workflow for CDM project team by monitoring enrollment information and communicating with project team to actively influence data collection

Monitor quality of work performed by CDM project team and compliance with GSOPs and provide feedback to team

Maintain CDM project budget by identifying CDM activities outside scope of contracted work, obtaining agreement from sponsor or CTI management prior to performing out-of-scope tasks, preparing or reviewing budget and cost analysis documentation routinely, and following scope issues through to resolution