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Medical Device Clinical Research Manager Jobs (NOW HIRING)

BiVACOR Inc

Clinical Research Manager

Huntington Beach, CA · On-site

$110K - $150K/yr

As a Clinical Research Manager, you will own end-to-end US IDE study operations, leading a team of ... Class III medical device experience an advantage * Can-do attitude, strategic thinker with strong ...

Envista

Clinical Research Manager

Brea, CA · On-site

$125K - $153K/yr

The Clinical Research Manager is responsible for managing all US clinical usability studies for ... Basic knowledge of medical device development processes * Ability to work in a diverse team ...

Stanford University

Clinical Research Manager

Stanford, CA · On-site

$124K - $153K/yr

The Tass Lab at Stanford University is seeking a Clinical Research Manager to provide leadership ... Knowledge of medical terminology. * Demonstrated managerial experience. CERTIFICATIONS & LICENSES:

Ambu

Clinical Data Manager

Columbia, MD · On-site

Clinical Research Department: Clinical Affairs Employment Type: Full-time Req ID: 10220 Job Title ... of medical device clinical studies designed to acquire clinical data that supports product ...

Horizon Clinical Research

Be Seen First

Clinical Research Assistant

Cypress, TX · On-site

$37K - $47K/yr

The CRA will work under the supervision of the Principal Investigator(s) and Site research manager ... Work closely with Principal Investigators (PIs) to assure subjects receive appropriate medical ...

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How much do medical device clinical research manager jobs pay per year?

As of Aug 13, 2026, the average yearly pay for medical device clinical research manager in the United States is $107,336.00, according to ZipRecruiter salary data. Most workers in this role earn between $81,000.00 and $122,500.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a medical device clinical research manager?

To thrive as a Medical Device Clinical Research Manager, you need a solid background in life sciences or engineering, experience with clinical trial management, and a thorough understanding of regulatory requirements such as FDA and ISO standards. Familiarity with electronic data capture (EDC) systems, clinical trial management systems (CTMS), and certifications like ACRP or SOCRA are highly beneficial. Exceptional leadership, problem-solving, and communication skills are crucial for coordinating cross-functional teams and managing complex projects. These skills ensure compliant, efficient, and successful clinical trials that bring safe and effective medical devices to market.

What does a medical device clinical research manager do?

A Medical Device Clinical Research Manager oversees the planning, execution, and management of clinical trials for new medical devices to ensure they meet regulatory and safety standards. They coordinate between research teams, regulatory bodies, and sponsors to ensure studies are conducted according to protocols and timelines. Their responsibilities include developing study protocols, managing budgets, ensuring data integrity, and ensuring compliance with regulatory requirements. This role is critical for bringing safe and effective medical devices to market.

What are some of the common challenges faced by medical device clinical research managers when overseeing clinical trials?

Medical Device Clinical Research Managers often encounter challenges such as ensuring compliance with complex regulatory requirements, managing timelines across multiple sites, and coordinating with diverse stakeholders including investigators, sponsors, and regulatory bodies. They must also address issues related to patient recruitment and data integrity while maintaining clear communication within cross-functional teams. Strong organizational skills and adaptability are essential to navigate these challenges and deliver successful clinical trial outcomes.
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Medical Device Clinical Research Manager jobs near you
Infographic showing various Medical Device Clinical Research Manager job openings in the United States as of August 2026, with employment types broken down into 100% Full Time. Highlights an 87% In-person, and 13% Remote job distribution, with an average salary of $107,336 per year, or $51.6 per hour.

Clinical Research Manager

BiVACOR Inc

Huntington Beach, CA • On-site

$110K - $150K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 18 days ago

Job description

Help Us Build the Future of the Human Heart.
At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every site you activate, every team member you develop, and every data point you interpret plays a direct role in giving patients another shot at life. If that's the kind of work that gets you out of bed in the morning, we think you belong here.
About the Role
This is a senior, high-impact leadership role at the center of BiVACOR's US clinical program, where your expertise will shape how we conduct, manage, and report on one of the most groundbreaking medical device studies of our time. As a Clinical Research Manager, you will own end-to-end US IDE study operations, leading a team of clinical research professionals, ensuring regulatory compliance across all active sites, and driving the clinical strategy that will help bring the world's first Total Artificial Heart to patients who need it most. You will bring deep clinical trial expertise, strong leadership instincts, and the scientific acumen to translate complex data into compelling, accurate clinical narratives.
Key Responsibilities
  • Manage all US IDE clinical study operations including site activation, enrolment, and monitoring
  • Lead and develop a team of Clinical Research Specialists/Site Managers and Clinical Research Associates
  • Ensure US sites maintain GCP compliance, FDA regulations, and protocol adherence
  • Serve as the primary liaison with US IRBs, site Principal Investigators, and study coordinators
  • Maintain the Trial Master File per ICH E6(R2) and ISO 14155:2020; prepare for and support inspections and audits
  • Collaborate on clinical strategy and author key clinical documents including clinical study protocols, clinical study reports, clinical evaluation plans/reports, annual progress reports, risk-benefit analyses, and clinical marketing materials
  • Develop a deep understanding of clinical data; interpret and communicate complex results in a clear, concise, and scientifically accurate manner across a wide range of audiences

What You Bring
  • Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or a related field; advanced degree preferred
  • 5+ years of clinical research experience in a medical device or pharmaceutical environment, with at least 3 years in a management or team leadership role
  • Extensive experience managing US IDE studies; thorough knowledge of FDA regulations (21 CFR 812), ICH E6(R2) GCP, and ISO 14155:2020
  • Demonstrated experience authoring regulatory and clinical documents including protocols, CSRs, CEPs/CERs, and annual progress reports
  • Strong data interpretation skills with the ability to synthesize complex clinical results and present them clearly to scientific, regulatory, and lay audiences
  • Prior experience with cardiac or implantable device studies strongly preferred; Class III medical device experience an advantage
  • Can-do attitude, strategic thinker with strong leadership and cross-functional communication skills
  • Willingness to travel to US clinical sites and attend key meetings and conferences as required

What We Offer
BiVACOR offers a competitive compensation package and comprehensive benefits, including:
  • 401(k) with company matching
  • Medical, dental, and vision insurance
  • Health Savings Account (HSA) & Flexible Spending Account (FSA)
  • Life insurance & Employee Assistance Program
  • Generous paid time off

This role may be based at BiVACOR's Huntington Beach headquarters. The expected salary range for this position based in Huntington Beach California is $110,000 - $150,000. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting.
Apply today and be part of something extraordinary.
BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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