Digital Medicine And Translational Imaging Study Manager
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 completenessAttend meetings with vendors and study staff to ensure proper site start-up and conductAddress troubleshooting or site-based issues related to digital medicine componentsConduct participant follow-ups as neededProcess Improvement
Identify opportunities and trends to enhance standardization and efficiency of operational activitiesCollate lessons learned, frequently asked questions, and study-specific exceptionsContribute to the continuous improvement of digital medicine assessment processesQualifications
Knowledge and Experience
Experience with trial management of Medical Device and / or Wearable Device studies is requiredExceptional knowledge of study management processes and deliverablesGood knowledge in understanding the responsibilities beyond their function to ensure goals are met for the studyMaintains expertise within the assigned therapeutic area and study to set the appropriate strategy, identify risks and to drive operational deliverablesWorking knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operationsExperience in clinical research or digital health technology implementationStrong attention to detail and data monitoring skillsExcellent communication and stakeholder management abilitiesProblem-solving mindset with ability to identify trends and improvement opportunitiesEducation
Bachelor's of Science or Bachelor's of Arts degree with a minimum 7 years of relevant operational clinical trial experience requiredMaster's of Science or Master's of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience requiredA scientific or technical degree is preferred along with extensive knowledge of clinical trial methodologyParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
