CTI Clinical Trial and Consulting Services · 21 hours ago
Clinical Data Manager
Covington, KY
Full-time
Hybrid
Entry, Mid Level
2+ years expCTI Clinical Trial and Consulting Services is seeking a Clinical Data Manager who will serve as the primary contact with sponsors and represent the DM group on project teams. The role involves overseeing the data cleaning process, developing study-specific documents, and maintaining communication with stakeholders throughout the project lifecycle.
BiotechnologyConsultingPharmaceutical
Responsibilities
Perform and/or 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
Develop and maintain study-specific documents including Case Report Forms, CRF Completion Guidelines, Clinical Data Management Plan, Annotated CRFs, and Edit Specifications
Serve as CTI CDM representative on project teams
Maintain positive working relationships with internal customers and Sponsors by keeping them up to date about the progress of projects and working with them to develop coordinated plans that meet customers’ needs
Maintain open and effective communication with internal and external customers by contacting Sponsor counterparts on an agreed-upon schedule, responding to correspondence promptly and within agreed-upon timeframes, and choosing the 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 before developing new methods
Develop and continuously evaluate timelines about work completed and communicate impact on milestones to CDM management, project team members, and Sponsor
Maintain a consistent, manageable workflow for the CDM project team by monitoring enrollment information and communicating with the project team to actively influence data collection
Monitor the quality of work performed by the CDM project team and compliance with GSOPs and provide feedback to the team
Develop project reports which meet the needs of sponsors, project team, and CTI management, are accurate, and are provided to sponsor and CDM management upon request or per a predefined schedule
Coordinate receipt and handling of data received from external sources (i.e., central laboratory, electrocardiogram [ECG], sponsor-coding dictionaries) and direct reconciliation where applicable
Prepare in advance for internal and external meetings, complete action items within the required timeframe, and attend internal meetings regularly, providing input, and demonstrating respect for the opinions of others
Maintain current study-specific documentation to accurately reflect process deviations and changes in project assumptions or the 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
Potential Additional Functions: Medical Coding, Database development and programming including functional testing, Clinical data review, Provide or arrange for adequate project-specific training for the CDM team and other study team members, Maintain the CDM project budget by identifying CDM activities outside the scope of contracted work, obtaining agreement from the sponsor or CTI management before performing out-of-scope tasks Potential Additional Functions: Recommend alternative work processes to improve the quality or speed of customer deliverables and respond to questions on the CDM process, timelines, and data quality
Qualification
Required
2 years of related Clinical Data Management experience in either a pharmaceutical or CRO environment
Bachelor's degree in nursing or life science and/or equivalent combination of education and clinical research experience
Benefits
Tuition reimbursement
Generous health benefits
Vacation packages
Hybrid work from home opportunities
Paid parental leave
Company
CTI Clinical Trial and Consulting Services
CTI is a full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services.
1001-5000 employees
H1B Sponsorship
CTI Clinical Trial and Consulting Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Timothy Schroeder
Chairman & CEO | Founder
Recent News
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2025-11-04
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