Clinical Research Manager

Synergy Spine Solutions; United States; On-site; USD 125,000 - 175,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading medical device company in the United States is seeking a Manager of Research & Clinical Affairs to lead U.S. IDE trials and post-market clinical studies. The ideal candidate will have over 5 years of clinical research experience, a relevant degree, and strong technical writing skills. You will ensure scientific integrity and regulatory compliance while collaborating with cross-functional teams. This role offers a competitive salary and benefits package.

Qualifications

• 5+ years of hands-on clinical research experience in the medical device industry.
• Proven track record managing clinical trials and post-market clinical studies.
• Experience working within medical device companies or CROs.

Responsibilities

• Oversee the conduct of U.S. IDE clinical trials and OUS post-market clinical studies.
• Draft, edit and review clinical abstracts, peer-reviewed publications, and CERs.
• Collaborate with cross-functional teams to support clinical strategy.

Skills

Strong technical writing skills

Deep understanding of FDA regulations

Strong communication skills

Education

Bachelor’s or Master’s degree in life sciences

Tools

CERs

Job description

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Synergy Spine Solutions provided pay range

This range is provided by Synergy Spine Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$125,000.00/yr - $175,000.00/yr

Additional compensation types

Annual Bonus and Stock options

Direct message the job poster from Synergy Spine Solutions

Synergy Spine Solutions is advancing cervical disc replacement through precision-engineered innovation and rigorous clinical evidence and validation.

About the Role

We’re seeking a Manager of Research & Clinical Affairs to lead our U.S. IDE trials and OUS post-market clinical studies, ensuring scientific integrity and regulatory compliance across global markets.

Responsibilities

• Oversee the conduct of U.S. IDE clinical trials and OUS post-market clinical studies
• Manage clinical research activities with our Clinical Research Organizations (CROs) in alignment with FDA and EU MDR requirements
• Serve as a liaison with clinical investigators, consultants, and regulatory bodies
• Draft, edit and review clinical abstracts, peer-reviewed publications, and Clinical Evaluation Reports (CERs)
• Collaborate with cross-functional teams (Regulatory, Marketing and R&D) to support clinical strategy and evidence generation
• Ensure timely execution of clinical milestones, site management, and data integrity
• Maintain audit-ready documentation and submission packages

Qualifications

• 5+ years of hands-on clinical research experience in the medical device industry
• Bachelor’s or Master’s degree in life sciences, biomedical engineering, or related field
• Proven track record managing clinical trials and post-market clinical studies
• Experience working within medical device companies or CROs

Required Skills

• Strong technical writing skills—CERs, publications, abstracts, protocols
• Deep understanding of FDA regulations, EU MDR, ISO 14155, and GCP
• Strong communication skills with clinicians and clinical research associates

Preferred Skills

• Experience with US IDE clinical trials and class III devices requiring PMA
• Experience in the spine medical device industry

Pay range and compensation package

Competitive compensation, equity, and benefits

Equal Opportunity Statement

Mission-driven culture focused on innovation and outcomes.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Science, and Writing/Editing

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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