Associate Medical Monitor, Medical Device CRO

🕒 April 29

🇺🇸 United States – Remote

💵 $83.5k - $162.9k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

📊 Conversion Rate Optimizer (CRO)

👻 Ghost score 45%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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NAMSA

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1967

🏥 Healthcare

🏭 Manufacturing

📦 Logistics

Healthcare • Manufacturing • Logistics

NAMSA is a global leader in medical device testing and research, offering comprehensive consulting, preclinical research, clinical research, and testing services for medical device and IVD manufacturers worldwide. With a team of over 1,400 specialists and state-of-the-art labs across North America, Europe, and Asia, NAMSA conducts extensive testing to ensure the safety, efficacy, and compliance of medical devices. The company provides strategic consulting on regulatory submissions and market strategies, helping clients navigate complex regulatory landscapes efficiently and effectively. Founded in 1967, NAMSA is trusted by manufacturers to deliver high-quality services from concept to commercialization.

📋 Description

• Comply with Safety Team Roles and Responsibilities • Perform medical review and interpretation of adverse events and device deficiencies reported by clinical trial investigators • Assess safety data in compliance with regulatory requirements, study protocols, and internal SOPs • Write and review adverse event narratives and ensure complete documentation • Utilize MedDRA for medical coding • Coordinate CEC and DSMB activities and oversee committee review materials • Review clinical study data, adverse event reporting, and clinical study design to safeguard trial subjects • Provide medical input into clinical study protocols, including safety endpoints, inclusion/exclusion criteria, and risk mitigation strategies • Oversee study-specific safety documents such as Safety Plans and CEC/DMC charters • Review and contribute to clinical evaluation reports, clinical study reports, aggregate safety reports, and regulatory submissions • Advise on protocol amendments based on safety data or regulatory feedback • Attend project and internal meetings • Assess adherence to timelines across involved groups • Serve as in-house Medical Subject Matter Expert for NAMSA projects • Participate in client kick-off and safety review meetings • Collaborate with biostatistics, regulatory, medical writing, and clinical operations teams • Participate in design, testing, and maintenance of electronic systems supporting safety services • Mentor and coach safety associates and non-medical team members • Develop and deliver training on therapeutic areas, safety processes, and protocol-specific topics • Support onboarding and departmental knowledge sharing • Participate in audits, inspections, and quality assurance activities • Ensure compliance with GCP and applicable regulatory guidelines • Maintain and develop SOPs, templates, and training materials • Track safety metrics and key performance indicators • Support invoicing and budget tracking for safety-related services • Document hours and expenses according to company policy

🎯 Requirements

• Doctor of Medicine degree with post-residency clinical experience • Minimum of 3 years of experience in clinical research or medical monitoring • Preferably experience with a Contract Research Organization and multiple classes of devices across various therapeutic areas, including cardiovascular, neurology, orthopedics, and urology • Experience with MedDRA coding, EDC systems, CEC adjudications, and DMC operations • Experience with global safety event reporting, especially EU MDR • Local travel may be required • Must be able to work independently • Must possess excellent verbal and written communication skills • Strong organizational skills with attention to detail • Ability to work in a fast-paced environment with multiple competing priorities • Proficiency in Microsoft Office and literature databases (e.g., PubMed, MedLine) • Strong understanding of GCP, ICH, FDA, and global regulatory requirements • Demonstrate a high degree of personal and professional integrity • Ability to talk or hear; stand, walk, sit, use hands, and reach with hands and arms • Ability to occasionally lift or move up to 50 pounds (23 kgs)

🏖️ Benefits

• Reasonable accommodations for individuals with disabilities • Local and occasional travel opportunities/requirements • Equal employment opportunity • Pre-employment background and drug screen processes aligned to local, state and federal laws