Study Manager (Wearables & Medical Devices) - FSP

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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.