top of page

Clinical Research Manager

Remote

Part-time

Position Description

Are you a healthcare research professional skilled at partnership development and shepherding programs to completion while staying on time and on budget? If you can efficiently advance research programs (with FDA submissions) toward their milestones while developing and supporting meaningful commercial partnerships, this position may be for you.

As a Clinical Research Manager (CRM), you will lead Miro Health’s clinical research programs in support of the company’s business goals. Your responsibilities will include partnering with Key Opinion Leaders, study sites, and commercial healthcare providers to implement, monitor, and ensure the success of Miro Health’s clinical studies and data collection for FDA regulatory approval.

Responsibilities

  • Manage study teams; ensure study compliance; report study progress to the NIH, IRBs, and FDA; work with internal product, engineering, and clinical colleagues to ensure study success

  • Plan and execute clinical study design, including management of data collection to prove clinical end points for multiple indications; work with partners and FDA consultants to ensure proper study design and execution; manage internal team to meet study goals

  • Design and launch new clinical research programs: Write grants, write papers; build R&D grants pipeline 

  • Collaborate with business development to identify partnerships with commercial providers and Key Opinion Leaders (KOLs) in areas of diagnostic interest; help build and grow our partnership pipeline including partnership outreach and development

  • Write or revise study protocols and IRB submissions; write and submit regulatory reports

  • Create budgets and negotiate contracts

  • Craft regular data-review and reporting protocols for study management and product improvement; identify and prioritize important product features 

  • Design and carry-out recruitment strategies for study participants 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 the role

  • MD, 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 is a plus

Compensation

Competitive salary, equity, healthcare coverage, flexible hours, sick leave and vacation

Apply Now
bottom of page