Senior Clinical Data Manager — CDM Lead

CTI Clinical Trial and Consulting Services; Portugal; Hybrid; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Health benefits

Vacation packages

Paid parental leave

Job summary

CTI Clinical Trial and Consulting Services in Portugal is seeking an experienced Clinical Data Management (CDM) professional to serve as the primary CDM contact with sponsors and represent the DM group on CTI project teams. You will lead data-management activities, manage study-specific documentation, and coordinate data workflows across projects.

The role includes developing and maintaining CDM documents, overseeing data cleaning from start-up through archival, and ensuring timely, high-quality

Qualifications

• 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 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
• 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, 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
• 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

Skills

CDM experience

Education

Bachelor’s degree in nursing or life science

Job description

CTI Clinical Trial and Consulting Services in Portugal is seeking an experienced Clinical Data Management (CDM) professional to serve as the primary CDM contact with sponsors and represent the DM group on CTI project teams. You will lead data-management activities, manage study-specific documentation, and coordinate data workflows across projects.

The role includes developing and maintaining CDM documents, overseeing data cleaning from start-up through archival, and ensuring timely, high-quality