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Precision for Medicine seeks a Clinical Scientist to perform scientific reviews of clinical data. The role involves ensuring data quality and consistency by applying protocol and oncology standards. The Clinical Scientist will collaborate with project teams, providing input on documentation and supporting data output testing. They will also assist in identifying quality risks and recommending corrective actions.
- Reviewing subject data for accuracy per protocol and oncology standards.
- Maintaining relationships with project team members.
- Collaborating with Medical Monitors and other departments.
- Providing input into project-related documentation.
- Supporting the development and User Acceptance Testing (UAT) of data outputs.
- Assisting with identification of quality risks and issues.
- Conducting UAT of programming output.
- Assisting in the development and implementation of strategy for an integrated data cleaning process.
- Reviewing and analyzing clinical trial data sources.
- Issuing and resolving queries in various EDC systems.
- Communicating effectively with the internal and external project team.
- Providing study-specific training for project teams.
- Developing applicable study-specific monitoring/CRA and data review tools.
- Participating in internal and external study-specific team meetings.
- Serving as a resource to the project team for scientific questions regarding data capture.
- Reviewing dictionary coding.
- Establishing task tracking metrics.
- Providing routine Project Management updates.
- Ensuring applicable eTMF documentation is provided and managed.
- Bachelor’s degree in science or healthcare discipline.
- Proficiency in medical terminology.
- At least two (2) years in clinical operations, data management, or related discipline.
- Experience in oncology clinical research.
- Oncology therapeutic experience.
- Experience with electronic data capture systems (EDC) and data visualization tools.
- Working knowledge of FDA & ICH/GCP regulations and guidelines.
- Remote work opportunity.
- Opportunity to work with a leading company in precision medicine.
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.