Lead Data Manager

This is a fully remote position, open to applicants in Spain, +4 more countries.

📋 Description

• Oversee comprehensive clinical data management start-up activities from protocol evaluation through the creation of specifications, database construction, testing, validation, and production launch.

• Analyze protocols to determine data collection needs, identify risks, inconsistencies, and their implications on database design or subsequent processes.

• Convert protocol requirements into study build specifications, covering visit schedules, assessments, eCRFs, dosing, data collection, and edit checks.

• Implement clinical data standards, including CDISC standards, principles of eCRF design, field and variable conventions, and approved standard forms.

• Collaborate with the Standards team to execute protocol-specific adaptations.

• Work alongside Study Execution Teams, Medical Data Review, Programming, Data Management, Standards, and other relevant stakeholders.

• Organize and supervise sandbox testing and user acceptance testing, which includes defect documentation, resolution, retesting, and confirmation of system readiness.

• Oversee timelines, dependencies, deliverables, risks, and issue resolution for database launch.

• Evaluate and manage the data management implications of protocol amendments and changes following go-live.

• Keep precise data management start-up documentation in the eTMF.

• Ensure that deliverables align with SOPs, ICH-GCP, regulatory standards, and internal quality benchmarks.

• Supervise daily clinical data science tasks and assist in team deliverables.

⛳️ Requirements

• Bachelor's degree in life sciences, computer science, or a relevant field.

• Significant experience in data analysis and project management within a clinical research environment.

• Advanced proficiency in statistical software and data visualization methods.

• Outstanding analytical and problem-solving abilities, focusing on converting data into actionable insights.

• Strong communication and leadership capabilities, with a talent for promoting collaboration among diverse teams.

• Willingness to travel as necessary (approximately 15%).

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where relevant.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.