Sr. Clinical Data Manager

Clinical Data ManagerEssential Functions: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 archivalServe as CTI CDM representative on project teamsRecommend alternative work processes to improve quality or speed of customer deliverables and respond to questions on CDM process, timelines, and data qualityMaintain 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' needsMaintain 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 communicatedEvaluate 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 methodsDevelop 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 requirementsContinuously evaluate timelines in relation to work completed and communicate impact on milestones to CDM management, project team members, and sponsorMaintain consistent, manageable workflow for CDM project team by monitoring enrollment information and communicating with project team to actively influence data collectionMonitor quality of work performed by CDM project team and compliance with GSOPs and provide feedback to teamMaintain 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 resolutionProvide or arrange for adequate project specific training for CDM team membersServe as a mentor to lower level Clinical Data Managers for all tasksDevelop project reports which meet needs of sponsors, project team, and CTI management, are accurate, and are provided to sponsor and CDM management upon request or a re-arranged scheduleCoordinate receipt and handling of data received from external sources (i.e., central laboratory, electrocardiogram [ECG], serious adverse events, etc.) and direct reconciliation where applicablePrepare in advance for internal and external meetings, complete action items within required timeframe, and attend internal meetings regularly, providing input, and demonstrating respect for opinions of othersMaintain current study documentation and CDM project plan which accurately reflect process deviations and changes in project assumptions or scope of contracted workConduct post-mortem analysis after study completion to determine positive and negative factors affecting the project and provide information along with study metrics to CDM managementCompetencies:Excellent verbal and written communication skillsKnowledge of regulatory guidelinesKnowledge regarding medical terminology and drug nomenclatureKnowledge of the drug development and clinical research processRequired Education/Experience:Bachelor's degree in nursing or life science and/or equivalent combination of education and clinical research experienceMinimum 5 years of related Clinical Data Manager experience in either pharmaceutical or CRO environment2 years of relational database experienceExperience with Medidata Rave or OmniComm, TrialMasterEqual Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. CTI