Miro is looking for a Clinical Research Manager with in-depth regulatory experience including successful FDA and reimbursement approvals and a strong background in study design, monitoring and management

 

CLINICAL RESEARCH MANAGER

The Clinical Research Manager is responsible for the health and success of Miro’s data collection program and for the maintenance of Miro’s regulatory compliance. This is a key regulatory role whose primary goal is to deliver an approved product into the marketplace.

 

Qualities that will bring success to this role 

The tendency to think 10-steps ahead. The advance identification and mitigation of potential problems, (well before IRB submission or first patient in), to ensure a successful FDA approval. Exceptional analytic, writing, organizational, project management and communication skills. Strong interpersonal skills. The ability to foster and maintain relationships with collaborating clinicians. Active awareness of NIH research trends and research activities of Key Opinion Leaders in the field. A roll-up-your-sleeves approach to preparing and maintaining studies and study materials for multiple sites.


RESPONSIBILITIES

 

Design and implement a regulatory strategy to support a rapid, successful market entry

Oversee and plan trial design, biomarkers and cognitive endpoints for multiple FDA claims and submissions; work with partners and FDA consultants to ensure proper study design

Set-up and manage data collection; write study protocols, IRB submissions, statistical analysis plans; negotiate contracts; write and submit regulatory and legal reports

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

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

Work with business development to design and carry-out recruitment strategies for participants of community studies, academic collaborators and pharmaceutical studies

Design and deploy Miro’s community-based study for longitudinal data collection from patient support communities

Ensure Miro’s ongoing compliance


REQUIREMENTS

 

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

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

Proven organizational efficiency, planning and execution skills

Track-record of gaining FDA and reimbursement approvals for medical devices

Natural problem solver and autonomous, self-starter

Strong people and project manager

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

5+ years of relevant work experience