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Job Description
Precision for Medicine is seeking a Clinical Scientist to perform early and continuing scientific review of clinical data. This role focuses on ensuring data quality and consistency in oncology clinical trials. The Clinical Scientist will collaborate with internal and external project teams, providing input into project documentation and supporting the development of data outputs. They will also assist in identifying quality risks and recommending corrective action plans.
Role Involves:
- 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 UAT of data outputs.
- Assisting with the identification of quality risks.
- Conducting UAT of programming output.
- Reviewing and analyzing clinical trial data sources.
- Issuing and resolving queries in EDC systems.
- Providing study-specific training for project teams.
- Developing study-specific monitoring and data review tools.
- Participating in team meetings.
- Reviewing dictionary coding.
- Establishing task tracking metrics.
- Providing project management updates.
- Ensuring eTMF documentation is managed.
Requirements:
- Bachelor’s degree in science or healthcare discipline.
- Proficiency in medical terminology.
- At least two 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.
- Proficient critical thinking, problem-solving, and decision-making skills.
- Professional use of the English language.
- Strong sense of teamwork.
- High self-motivation and ability to work independently.
- Practical knowledge of IT tools and systems.
Role Offers:
- Opportunity to work remotely.
- Chance to collaborate with internal and external project teams.
- Involvement in various aspects of clinical data review and analysis.
