Sr. Clinical Data Manager

Join The CTI Team•Covington, KY

About The Position

The Clinical Data Manager (CDM) will direct the activities of CDM team members to ensure project deliverables are met on schedule, within quality standards, and according to project budget from study start-up through archival. This role serves as the CTI CDM representative on project teams, recommending process improvements and maintaining positive working relationships with internal and external customers. The CDM will maintain open communication, evaluate team requests, develop and maintain CDM study files, and establish time estimates for deliverables. They will specify data cleaning guidelines, conventions, Global Standard Operating Procedures (GSOP), data workflow, and other processes to meet sponsor requirements. Continuous evaluation of timelines and communication of impacts to management and team members are crucial. The CDM will monitor team workflow, ensure quality of work and compliance with GSOPs, and manage the CDM project budget by identifying and addressing out-of-scope tasks. They will also provide or arrange for project-specific training, mentor junior CDM staff, develop project reports, coordinate data receipt from external sources, prepare for and attend meetings, and maintain current study documentation. A post-mortem analysis after study completion is also required.

Requirements

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
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

Responsibilities

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
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