Clinical Study Manager, Digital Medicine & Translational Imaging

Clinical ResearchClinical ResearchFull TimeRemoteLeadTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

Not specified

Seniority

Lead

Bachelor Degree7 yrs expEnglish

Job Description

• 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.

Job 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

  • Health insurance
  • 401(k) matching
  • Flexible work arrangements
  • Professional development opportunities

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