Clinical Scientist, Clinical Science Analytics and Insights

Precision Medicine Group; United States; Remote; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Clinical Scientist to join their innovative team. This role involves reviewing clinical data to ensure accuracy and consistency, while applying oncology standards to enhance data quality. The ideal candidate will work collaboratively with cross-functional teams, leveraging their expertise in clinical operations and oncology. If you're passionate about making a difference in the field of precision medicine and possess strong analytical skills, this opportunity offers a chance to contribute to groundbreaking oncology research in a supportive remote environment.

Qualifications

• 2+ years in clinical operations or data management in CRO or pharma.
• Experience in oncology clinical research as a Study Coordinator or CRA.
• Proficiency in medical terminology and oncology standards.

Responsibilities

• Review clinical data for accuracy per protocol and oncology standards.
• Collaborate with project teams to ensure data quality and consistency.
• Conduct User Acceptance Testing of data outputs and EDC systems.

Skills

Oncology Standards

Clinical Trial Methodology

Data Management

Critical Thinking

Problem Solving

Education

Bachelor’s Degree in Science or Healthcare

Medical Related Degree (RN, OCN, PharmD)

Tools

Electronic Data Capture Systems (EDC)

Data Visualization Tools

Microsoft Office Suite

Job description

Precision for Medicine is seeking an experienced Clinical Scientist to work remotely from Poland, Hungary, Serbia, Romania, or Slovakia.

Job Summary:

The Scientist, Clinical Science Analytics and Insights, conducts early and ongoing scientific review of clinical data in various formats. By applying the protocol and oncology standards for the studied indication, they support data quality and consistency, providing insights for a continuous risk management approach.

Essential Functions:

1. Review subject data for accuracy according to protocol, references, and oncology standards to ensure data quality and consistency.
2. Develop and maintain relationships with internal and external project team members, promoting Precision’s high standards and ethical image.
3. Collaborate with CSAI-OS management, Medical Monitors, and other departments to support data review trends and meet project deliverables in compliance with GCP/ICH, protocols, and SOPs.
4. Contribute to project documentation such as EDC specifications and review guidelines, coordinating patient reviews with relevant departments.
5. Support the development and testing of data outputs with CSAI-OS Programming.
6. Utilize various EDC systems and data visualization tools.
7. Serve as a scientific resource for project teams, addressing clinical and oncology questions.
8. Provide status updates, escalate issues, and assist in identifying and correcting data quality risks.
9. Conduct UAT of CSAI-OS outputs and participate in EDC UAT processes.
10. Review protocols from a scientific-operational perspective and assist in study-specific document development.
11. Develop strategies for integrated data cleaning across departments.
12. Review and analyze clinical trial data sources throughout the trial to ensure accuracy and adherence to clinical and oncology standards.
13. Manage queries in EDC systems and communicate data quality issues to relevant teams.
14. Provide training on CSAI-OS procedures and develop monitoring tools.
15. Participate in study team meetings and serve as a scientific data capture resource.
16. Review coding dictionaries and establish metrics to monitor trial progress.
17. Maintain documentation related to CSAI-OS and perform other duties as assigned.

Qualifications:

Minimum Required:

• Bachelor’s degree or equivalent in science or healthcare with proficiency in medical terminology.

Other Required:

• At least two years in clinical operations, data management, or related oncology research experience, preferably as a CRA or Study Coordinator/Nurse.
• Oncology therapeutic experience and knowledge of oncology standards are required.
• Experience with EDC systems and data visualization tools is preferred.
• Knowledge of FDA & ICH/GCP regulations.

Preferred:

• Medical degree or related qualification such as RN, OCN, PharmD, etc.

Skills and Competencies:

• Ability to work remotely with minimal supervision, applying oncology and clinical trial knowledge.
• Strong understanding of oncology standards and clinical trial methodology.
• Continuous learner, adaptable, professional, and proactive in problem-solving.
• Excellent communication, teamwork, and organizational skills.
• Proficient in IT tools, including Microsoft Office, EDCs, EMRs, and data visualization tools.
• Willing to travel up to 25% domestically and internationally.

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