Biostatistician – Clinical Trials, Drug/Biologic
axogen
Clinical Study Manager, Digital Medicine & Translational Imaging
Parexel
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
SeniorLead
About the role
- 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.
- 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.
Requirements
- 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
- 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.
Benefits
- EEO Disclaimer
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
trial managementdata quality monitoringdigital health technology implementationclinical researchGood Clinical Practices (GCPs)monitoringclinical operationsregulatory operationsdata monitoringclinical trial methodology
Soft skills
attention to detailcommunicationstakeholder managementproblem-solvingoperational deliverablesstrategic thinkingrisk identificationtrend analysisprocess improvementcollaboration
