Sr Clinical Data Manager

Ctifacts; Lisboa; Híbrido; EUR 55 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work from home opportunities

Health benefits

Resumo da oferta

CTI is seeking a CDM Lead in Portugal to drive study-specific data management activities from start-up through archival. You will develop essential CDM documents, serve as the project team's CDM representative, and coordinate data receipt from external sources while ensuring quality standards and timelines.

The role requires strong communication with Sponsors and internal customers, management of timelines, and adherence to GSOPs.

Qualificações

• 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

Responsabilidades

• 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, 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

Conhecimentos

CDM experience

Formação académica

Bachelor’s degree in nursing or life science

Descrição da oferta de emprego

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.

What You’ll Do:

• 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

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

What You’ll Bring:

• 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

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.