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Clinical Research Manager

San Francisco, CA | careers@mirohealth.com

About the position

The Clinical Research Manager (CRM) is responsible for the success of Miro’s FDA applications and data collection program. As CRM, you will lead our data collection efforts. This includes managing staff to efficiently complete data collection and managing relationships with researchers at leading institutions and CROs. A large part of your day will be spent on enrollment tracking, collaborating with researchers at academic institutions and CROs, writing contracts and IRB submissions, ensuring adherence to GCP/FDA Guidance, working with the product team to ensure clinical adherence and value, and preparation of evidence for FDA submission. This is a key role whose primary goals are to continually improve our science, maintain research collaborations, loop feedback from collaborators and participants back to the product team, and ensure regulatory compliance.

Responsibilities

  • Spearhead and manage ongoing data collection; write or revise study protocols, IRB submissions, statistical analysis plans; create budgets; negotiate contracts

  • Plan and execute clinical study design, including management of data collection via various endpoints for multiple FDA claims and submissions; work with partners and FDA consultants to ensure proper study design

  • Ensure successful study completion and publication of findings in peer-reviewed journals

  • Write and submit regulatory reports for during both the pre- and post-market phase

  • Craft regular data-review and reporting protocols both for trial management and to support product improvement; identify and prioritize features to support rapid marketplace adoption

  • Collaborate with business development to identify partnerships with KOLs in areas of therapeutic interest

  • Design and carry-out recruitment strategies for participants of community studies, and support recruitment efforts of academic and industry collaborators

  • Ensure Miro’s ongoing compliance and legal processes in accordance with ICH-GCP, FDA and ISO standards.

Requirements

  • MPH, PhD or RN (preferred) with experience establishing and running clinical studies

  • Strong knowledge of regulatory requirements governing clinical studies (HIPAA, GCP, FDA)

  • Proven organizational efficiency, planning and execution skills

  • Natural problem solver and autonomous, self-starter

  • Flexible and adaptable to the needs of a young, mission-driven company

  • 5+ years of relevant work experience

Qualities that will bring success to this role

  • A roll-up-your-sleeves, get-it-done work style

  • Strong ability to prioritize and maintain focus

  • Exceptional communication, organizational, people, and project management skills

  • Detail-oriented with a tendency to think 10-steps ahead

  • Ability to foster and maintain close relationships with a broad range of people

  • CCRP Certification by SoCRA or ACRP or coursework in clinical trial management a plus

Compensation

Competitive salary, equity, full healthcare coverage, flexible hours and vacation

At this time, we are unable to support H1B Visa transfers or applications.