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Senior Clinical Trial Manager

Aveera Medical
Remote

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Job Details

Full-time
$125,000 - $175,000 a year
13 days ago

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance
Retirement plan

Qualifications

Regulatory inspections
Clinical compliance checks
Good Clinical Practice (GCP)
Clinical research audit management
Operational management
Operations coordination
Medical scheduling
Research project coordination
Clinical audit and monitoring
Clinical data entry
Organizational skills
Relationship management
Regulatory readiness in healthcare
Biomedical regulatory compliance
Clinical quality assurance standards
Achieving project delivery timelines
Process management
Quality data entry
FDA regulations
Audit support

Full Job Description

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

Quick Apply

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