Associate Manager, Digital Study Operations

San Mateo, California, United States Full-time

Position Description

Evidation Health is seeking a motivated candidate who is passionate about defining value within digital health as a member of an agile, entrepreneurial team. As an Associate Manager, Digital Study Operations, you will engage with an experienced cross-functional team to lead the setup and execution of digital health studies.

You will be responsible for managing technical Clinical Research Associates and overseeing study product configuration, protocol compliance and data quality monitoring, and other study management activities for a range of studies across the portfolio. As a member of the Health Outcomes Research team, you will collaborate with the project management and product/engineering teams to ensure clinical studies meet or exceed high quality standards. This role is based in San Mateo, CA. 

 

Responsibilities

  • Lead the Digital Study Operations sub-team responsible for the following activities for all prospective studies:
    • Conduct study setup activities including configuring proprietary study product according to protocol
    • Conduct study product QA, ensure team’s launch checklist is complete, and collaborate with Engineering and Product teams to ensure seamless study launches
    • Set up study operation processes by developing protocol compliance, data quality monitoring, and participant outreach plans to execute and monitor daily
    • Validate data and facilitate participant data collection throughout study period daily
    • Collaborate with Project Operations and Study Support teams to address study or participant questions/issues
    • Track and report on study metrics regularly during recruitment, enrollment, and data collection phases
    • Aggregate and clean study datafiles for analysis
  • Manage 2 or more technical Clinical Research Associates, including task management and oversight and professional development and mentorship
  • Develop expertise in the functionality and use of a proprietary study platform, and utilize expertise to advise on protocol development for new studies
  • Conduct research and analysis utilizing study operations data to improve internal research processes and contribute to broader understanding of research best-practices
  • At times, assist in preparing and reviewing IRB submissions, informed consent forms, case report forms, and patient support materials
  • Participate in study setup and management process improvement activities within the department and cross functionally, including SOP development
  • Participate in proprietary study product development planning and feedback sessions
  • Minimal travel possible; may occasionally attend client meetings or conferences

 

Desired Skills and Experience

  • Undergraduate university degree required
  • 5+ years of work experience required, team management experience preferred
  • Clinical research experience required, experience with clinical trials preferred
    • Familiarity with HIPAA, human subjects research, and good clinical practices required
  • Data management experience and familiarity with interpreting quantitative analysis
  • Proven ability to develop technical product expertise, which could include implementing an electronic data capture system or collaborating with product/engineering teams
  • Efficient multi-tasker able to juggle multiple projects in various phases simultaneously
  • Strong project management, organizational, and interpersonal communication skills
  • Excellent attention to detail
  • Works well with minimal direction at times
  • Proficient in: Google docs and sheets; Microsoft Word, Excel, and PowerPoint

Apply for this opening at http://evidation.recruiterbox.com/jobs/fk01qmz?apply=true