Clinical Study Manager, Digital Medicine & Translational Imaging - 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 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 #LI-LG4 EEO Disclaimer Parexel 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. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40 years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™