Position Clinical Research Manager
Location San Francisco, CA
Job Description Clinical Research Manager
San Francisco | http://mirohealth.com | careers@mirohealth.com

About the position
As 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