Senior Clinical Data Manager - Lead CDM Strategy & Delivery

Join The Cti Team; Lisboa; Hybrid; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Health benefits

Vacation package

Paid parental leave

Job summary

Join The Cti Team seeks a Sr Clinical Data Manager to act as the primary CDM contact with sponsors and lead study-specific CDM activities from start-up through archival. You will develop and maintain essential CDM documents and oversee data cleaning, testing, and validation, coordinating data from external sources.

The role requires 2+ years in CDM within pharma/CRO settings, a nursing or life science degree, and strong communication with sponsors and internal teams.

Qualifications

• 2 years of related Clinical Data Management experience in 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.

Job description

Join The Cti Team seeks a Sr Clinical Data Manager to act as the primary CDM contact with sponsors and lead study-specific CDM activities from start-up through archival. You will develop and maintain essential CDM documents and oversee data cleaning, testing, and validation, coordinating data from external sources.

The role requires 2+ years in CDM within pharma/CRO settings, a nursing or life science degree, and strong communication with sponsors and internal teams.