About the Role
Aveera Medical is conducting the Boomerang pDVA study, a U.S. FDA IDE clinical trial of a novel medical device, currently enrolling toward a target of 120 patients across a growing network of clinical sites. We are seeking an experienced Clinical Trial Manager to serve as the primary operational and relationship link between Aveera and its investigational sites.
This is a hands-on, site-facing role for a seasoned clinical operations professional who understands what coordinators and investigators need to succeed. Beyond day-to-day execution, this person will help stand up the study-management systems the trial needs as it scales — data-timeliness discipline, a structured query-resolution process, and clear operational metrics — and will help keep sites inspection-ready. The ideal candidate is equally comfortable troubleshooting a data issue with a coordinator and building the process that prevents that issue from recurring.
Key Responsibilities
Site Relationship & Operations Management
- Serve as primary point of contact for assigned clinical sites, building trusted working relationships with study coordinators and investigators.
- Own patient follow-up scheduling — proactively track upcoming visit windows and work with coordinators to ensure patients are scheduled and seen per protocol.
- Support site onboarding and activation in coordination with the Directors of Clinical Site Operations and Field Clinical Operations.
- Escalate and resolve site-level operational issues, engaging internal stakeholders when a site is at risk or unresponsive.
Data Timeliness & Query Resolution
- Drive timely and accurate data entry by sites into the EDC (Medrio), monitoring CRF completion against enrollment and visit activity.
- Own the query lifecycle — partner with sites to issue, track, and close data queries, and help establish a standardized query-resolution cadence and workflow.
- Support data cleaning for interim analyses, monitoring visits, and regulatory reporting.
Imaging & Core Lab Coordination
- Coordinate imaging submissions and resolve data discrepancies with the imaging core lab, ensuring sites remain current on uploads and proper data entry.
- Track imaging compliance across sites and follow up on outstanding or rejected submissions.
Audit Readiness & Systems Building
- Prepare clinical sites for FDA audits and inspections — lead readiness activities, mock audits, and corrective follow-up to keep sites inspection-ready.
- Help build and maintain study-management systems — including study dashboards / operational metrics, query-resolution processes, and data-timeliness tracking — that currently need to be established or matured.
- Document workflows and create repeatable processes as the site network grows toward full enrollment.
Required Qualifications
- Minimum 7 years of experience managing clinical studies, with demonstrated ownership of multi-site trial operations.
- Experience on medical device / FDA IDE trials, with working knowledge of GCP and applicable FDA regulations (21 CFR Parts 812, 50, 56).
- FDA site audit experience, including hands-on preparation of clinical sites for FDA inspection and readiness activities.
- Prior clinical research site experience as a study coordinator (CRC) or equivalent, with first-hand understanding of coordinator workflows, EDC data entry, and visit scheduling.
- Strong organizational skills and the ability to manage multiple sites and competing priorities independently.
- Excellent interpersonal and communication skills, able to build rapport with sites and hold them accountable to timelines.
Preferred Qualifications
- Contributed to a successful PMA approval — prior experience on a study that achieved FDA Premarket Approval.
- ACRP certification (or equivalent, e.g., SOCRA).
- Strong professional network across clinical sites, investigators, and CRO / vendor partners.
- Hands-on experience with Medrio (or comparable EDC) and imaging core-lab submission platforms.
- Familiarity with the peripheral vascular / DVA, wound care, or diagnostic ultrasound therapeutic space.
Pay: $125,000.00 - $175,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Retirement plan
- Vision insurance
Application Question(s):
- What do you enjoy most about being involved in clinical studies?
Work Location: Remote
