Medical Data Review and Analysis Lead
hace 2 semanas
We are seeking a highly skilled Medical Data Review and Analysis Lead to join our team at Fortrea, a leading global contract research organization. This role offers an exciting opportunity to work on various clinical development projects across multiple therapeutic areas.
Key Responsibilities:
- Collaborate with cross-functional teams to develop Central Monitoring proposal text and review costing.
- Contribute to proposal strategy and development when Central Medical Review is included.
- Support Sponsor presentations and bid defenses.
- Evaluate data to recommend patient safety concerns.
- Identify and assess safety signals based on individual cases and cumulative data analysis.
- Develop the Risk Assessment and Categorization Tool for medical review-related topics.
- Support Data Experts with Critical Data and Process Definition and EDC design implementation.
- Draft and finalize the Central Medical Review Configuration Plan.
- Manage the configuration of the Medical Review (XMR) tool and program study-specific visualizations in XMR.
- Perform ongoing Central Medical Review, discuss findings with Project Physicians, and ensure identified issues are resolved.
- Provide data-driven decisions and communicate these findings effectively to key stakeholders.
- Take responsibility for inspection readiness for medical assessment activities.
- Collaborate with Central Monitoring activities to ensure consistency and effectiveness.
- Evaluate and submit process improvement suggestions to leadership.
- Provide training on the project and process to new team members.
Benefits:
- A competitive salary range of $120,000 - $160,000 per annum, depending on experience.
- A comprehensive benefits package, including health insurance, retirement plans, and paid time off.
- Ongoing professional development opportunities and access to cutting-edge technologies.
- A dynamic and inclusive work environment that values diversity and promotes employee well-being.
Required Skills and Qualifications:
- Master's or Ph.D. degree in a relevant life sciences field, such as medicine, pharmacy, or biomedical sciences.
- Minimum 5 years of experience in medical data review and analysis, preferably in a contract research organization (CRO) setting.
- Excellent analytical and problem-solving skills, with the ability to interpret complex data sets.
- Strong communication and collaboration skills, with the ability to work effectively with cross-functional teams.
- Proficiency in software applications, such as Microsoft Office and EDC systems.
About Fortrea:
Fortrea is an equal opportunities employer, committed to diversity and inclusion in the workforce. We do not tolerate harassment or discrimination of any kind and strive to create a work environment that values and respects all employees. If you are passionate about working in a dynamic and innovative company, please apply for this exciting opportunity
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