Clinical Data Manager

CTI Clinical Trial and Consulting Services•Covington, KY

2d•Hybrid

About The Position

This person will serve as the primary CTI Clinical Data Management (CDM) contact with sponsors and represent the DM group on CTI project teams. Responsible for study-specific CDM document development and maintenance, project status to the CTI project team, CDM management, and sponsors. Also, they are responsible for the data cleaning process from start-up through data archival, developing and/or approving project database builds, testing, and validation. Finally, they will coordinate the receipt and processing of information for projects (e.g., coding dictionaries) as well as third-party electronic data utilized on projects.

Requirements

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

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
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
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