DIREC002038
Essential 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 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
• Provide or arrange for adequate project specific training for CDM team members
• Serve as a mentor to lower level Clinical Data Managers for all tasks
• Develop 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 schedule
• Coordinate receipt and handling of data received from external sources (i.e., central laboratory, electrocardiogram [ECG], serious adverse events, etc.) and direct reconciliation where applicable
• Prepare 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 others
• Maintain current study documentation and CDM project plan which accurately reflect process deviations and changes in project assumptions or scope of contracted work
• Conduct post-mortem analysis after study completion to determine positive and negative factors affecting the project and provide information along with study metrics to CDM management
Competencies:
• Excellent verbal and written communication skills
• Knowledge of regulatory guidelines
• Knowledge regarding medical terminology and drug nomenclature
• Knowledge of the drug development and clinical research process
• Excellent written and oral communication skill
Required Education/Experience:
• Bachelor’s degree in nursing or life science and/or equivalent combination of education and clinical research experience
• Minimum 5 years of related Clinical Data Manager experience in either pharmaceutical or CRO environment
• 2 years of relational database experience
• Experience with Medidata Rave or OmniComm, TrialMaster