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Study Manager (Medical Devices) - FSP
応募 求人ID R0000036140 ロケーション メキシコ合衆国 仕事内容Job Summary
The Study Manager is part of the (DMTI - Digital Medicine and Translational Imaging) group, that looks to develop and implement novel technologies to support company’s portfolio studies. In particular for this role, Digital Medicine focuses on the deployment of digital health technologies (DHTs) to objectively, remotely, and continuously assess a patient over time using novel digital endpoints.
Job Responsibilities:
The DMTI Study Manager would be critical in ensuring the digital medicine data collected across multiple studies is of the highest quality. To facilitate this will require reviewing and monitoring multiple dashboards to discern if data is being collected as expected, and if there are any necessary actions or issues for follow-up. Some examples include: confirming whether the participant is in an ‘active wear’ period based on the protocol (ie, when they should be wearing the device), and if so, whether they are wearing it compliantly (based on pre-specified criteria), if data is being transmitted as expected, and if the battery/memory capacity of the device meets operational requirements.
Additional activities would include reviews of participant and site guides, attending meetings with vendors and study staff to ensure sites have appropriate materials for start-up and conduct, to surface or discuss any troubleshooting or site-based issues related to the digital medicine portion of the study, and to conduct any pertinent participant follow-ups.
In operating across multiple DMTI studies, the DMTI Study Manager will be key in identifying opportunities and trends to better enhance the standardization and efficiency of operational activities associated with these assessments. Examples include: collating list of lessons learned, frequently asked questions, and any study specific exceptions.
Qualifications & Prior Experience
Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology
BA/BS 7+ years of relevant experience
MBA/MS/ 6+ years of relevant experience
English is required.
Demonstrated clinical research experience and/or study management experience
Demonstrated study management/leadership experience
Demonstrated oversight of vendors
Demonstrated experience in medical devices.
