Proficient in Medidata Rave or OmniComm, TrialMaster
Deep understanding of clinical research and drug development processes
Responsibilities
Direct CDM team to ensure timely project deliverables
Serve as CDM representative on project teams
Recommend process improvements for quality and speed
Maintain communication with internal customers and sponsors
Evaluate team requests considering efficiency and quality
Develop and maintain comprehensive CDM study files
Monitor project timelines and adjust as necessary
Benefits
Ongoing training opportunities for team members
Supportive mentorship for career development
Collaboration with diverse project teams
Access to industry-standard tools and technologies
Opportunities for improving work processes and deliverables
Full Job Description
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
