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Precision for Medicine seeks a Clinical Scientist to perform scientific reviews of clinical data. This role supports data quality and consistency by applying oncology standards. The Clinical Scientist will work remotely from Poland, Hungary, Serbia, Romania, or Slovakia.
Responsibilities:
- Reviews subject data for accuracy per protocol and oncology standards.
- Maintains relationships with project team members.
- Collaborates with management and Medical Monitors on data capture trends.
- Provides input into project documentation.
- Supports the development and UAT of data outputs.
- Assists with identification of quality risks and recommends corrective action plans.
- Conducts UAT of programming output and participates in EDC UAT.
- Reviews and analyses clinical trial data sources.
- Issues and resolves queries in EDC systems.
- Communicates data quality issues and implements necessary actions.
- Provides study-specific training for project teams.
- Develops study-specific monitoring and data review tools.
- Participates in team meetings.
- Reviews dictionary coding.
- Establishes task tracking metrics.
- Ensures eTMF documentation is managed.
Requirements:
- Bachelor’s degree in science or healthcare.
- Two years in clinical operations, data management, or related discipline.
- Experience in oncology clinical research.
- Experience as a Clinical Research Associate (CRA) or Study Coordinator/Research Nurse preferred.
- Oncology therapeutic experience.
- Experience in phase I, II and III oncological trials preferred.
- Experience with electronic data capture systems (EDC) and data visualization tools preferred
- Computer proficiency
- Working knowledge of FDA & ICH/GCP regulations and guidelines.
The role offers:
- Remote work opportunity
Precision Medicine Group
Precision Medicine Group is a specialized company operating in the financial and operational aspects of project management, particularly within the Clinical Research Organization (CRO) industry. They excel in managing and coordinating change orders, working closely with project management, financial analysts, and functional leads. Their expertise lies in providing detailed variance analysis, budgeting, financial forecasting, and maintaining meticulous financial records. They ensure regulatory compliance and adapt to evolving project requirements. The company emphasizes accuracy, strategic communication, and collaboration with both internal teams and external stakeholders.