Clinical Research Manager

Website Miro Health

Clinical Research Manager

San Francisco  |  http://mirohealth.com  | careers@mirohealth.com

About the position

As a Clinical Research Manager (CRM), you will lead our clinical research programs. This includes partnering with Key Opinion Leaders and study sites to implement, monitor, and shepherd to completion Miro’s clinical studies for FDA regulatory submission. Primary goals include the insurance of our data integrity and study compliance (adherence to GCP / FDA Guidelines), the collection of feedback from collaborators and participants, the communication of feedback to the product team, the establishment and maintenance of external collaborations, study supervision, and preparation of evidence for FDA submission.

Responsibilities

  • 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 and execution
  • Write or revise study protocols and IRB submissions; write and submit regulatory reports
  • Create budgets and negotiate contracts
  • Collaborate with business development to identify partnerships with KOLs in areas of therapeutic interest
  • 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
  • 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

  • 5+ years experience establishing and running clinical studies or clinical trials
  • 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

Qualities that will bring success to this role

  • MPH, PhD or RN (preferred)
  • 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
  • Comfortable with ambiguity and shifting priorities
  • 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, healthcare coverage, flexible hours and vacation

Miro: Do well by doing good

To apply for this job email your details to sarah@mirohealth.com