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Clinical Data Scientist 1
hace 2 meses
We are seeking a highly skilled Clinical Data Scientist 1 to join our team at Almirall. As a key member of our Clinical Data Management team, you will be responsible for ensuring the quality and integrity of clinical trial data.
Key Responsibilities- Data Management: Oversee the capture, integration, and storage of clinical trial information, ensuring adherence to international standards and regulations.
- Protocol Review: Review clinical trial protocols to ensure alignment with Almirall's data management processes and standards.
- eCRF and ePRO Management: Lead the review and approval of electronic Case Report Forms (eCRFs) and electronic Patient Reporting Outcomes (ePROs), ensuring compliance with data standards and regulations.
- Data Quality Assurance: Manage data findings and processes during trial conduct, ensuring alignment with data standards and regulations.
- Database Management: Set up and manage databases, ensuring data quality and integrity.
- CRO Management: Coordinate with Contract Research Organizations (CROs) to ensure data availability and quality.
- Closure and Lock: Manage database lock processes, ensuring data quality and integrity before database lock approval.
- Documentation Provision: Provide necessary documentation to CROs for outsourced activities.
- Quality Oversight: Monitor and report on quality and deliverables of CRO Data Management activities.
- Regulatory Compliance: Participate in inspections and provide technical advice on data management methodologies and processes.
- Professional Development: Stay up-to-date with new standards, systems, and processes, and participate in professional development activities.
To be successful in this role, you will need to have a strong background in clinical data management, excellent communication and project management skills, and the ability to work in a fast-paced environment.
