Clinical Study Manager, Digital Medicine & Translational Imaging - FSP
Job Summary: The Digital Medicine and Translational Imaging Study Manager will play a critical role in ensuring the quality of digital medicine data collected across multiple portfolio studies. This position supports the Digital Medicine and Translational Imaging group's mission to develop and implement novel technologies, with a specific focus on digital health technologies that objectively, remotely, and continuously assess patients over time using novel digital endpoints. Key Responsibilities: Data Quality Monitoring
- Review and monitor multiple dashboards to ensure data is being collected as expected
- Verify participant compliance with device wear periods as specified in protocols
- Monitor data transmission and device performance (battery/memory capacity)
- Identify and follow up on necessary actions or issues
Operational Support
- Review participant and site guides for accuracy and completeness
- Attend meetings with vendors and study staff to ensure proper site start-up and conduct
- Address troubleshooting or site-based issues related to digital medicine components
- Conduct participant follow-ups as needed
Process Improvement
- Identify opportunities and trends to enhance standardization and efficiency of operational activities
- Collate lessons learned, frequently asked questions, and study-specific exceptions
- Contribute to the continuous improvement of digital medicine assessment processes
Qualifications: Knowledge and Experience
- Experience with trial management of Medical Device and/or Wearable Device studies is required
- Exceptional knowledge of study management processes and deliverables
- Good knowledge in understanding the responsibilities beyond their function to ensure goals are met for the study
- Maintains expertise within the assigned therapeutic area and study to set the appropriate strategy, identify risks and to drive operational deliverables
- Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations
- Experience in clinical research or digital health technology implementation
- Strong attention to detail and data monitoring skills
- Excellent communication and stakeholder management abilities
- Problem-solving mindset with ability to identify trends and improvement opportunities
Education
- Bachelor's of Science or Bachelor's of Arts degree with a minimum 7 years of relevant operational clinical trial experience required
- Master's of Science or Master's of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required
- A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology
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