Clinical Study Manager

🔥 22 hours ago

🇺🇸 United States – Remote

💵 $83.5k - $162.9k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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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

• Develop and maintain foundational clinical study materials and tools • Coordinate team and client review processes • Create and manage study tracking tools, metrics, systems, and reporting • Support protocol training, client and site management, and escalation and resolution of site issues • Establish and monitor project metrics and track project deliverables • Communicate project status to clients and internal teams • Facilitate team and sponsor meetings and follow action items to resolution • Drive site activities from start-up through close-out, including site selection, qualification, submissions, document collection, contracting, initiation, enrollment, monitoring, engagement, and close-out • Monitor data quality, site compliance, adverse events, protocol deviations, and site communications • Troubleshoot site and team issues and potentially implement CAPAs • Drive project-level deliverables and maintain current, consistent project plans and TMF-level documents • Ensure Trial Master File quality and audit readiness • Assist with development, testing, and implementation of EDC, CTMS, TMF, and device-accountability systems • Work with data management and biostatistics to develop reports and listings and review data trends • Assist with clinical deliverables for regulatory submissions • Develop clinical study reports • Ensure compliance with contractual agreements, SOPs, ICH Guidelines, and applicable regulations • Lead multidisciplinary clinical projects for simple to moderately complex studies • Manage cross-functional groups • Understand investigational products and the medical device development process • Review monitoring reports • Conduct and summarize literature searches • Assist with clinical audits, regulatory inspections, and sponsor/vendor audits • Organize and manage Investigator Meetings • Select and manage Core Laboratories • Select and manage safety committees such as DSMB or CEC

🎯 Requirements

• Bachelor’s degree or equivalent experience in a related field • Minimum 3 years of relevant clinical trial and/or monitoring experience • Project management experience • Fluency in English and local language, if different • Knowledge of Good Clinical Practices • Knowledge of regulations applicable to medical device trials at various development stages • Familiarity with the clinical trial process • Understanding of site escalation processes for compliance issues • Multidiscipline therapeutic knowledge in at least 2 therapeutic areas • Familiarity with medical device development from pre-clinical to commercialization • Understanding of data management and biostatistics in clinical trials • Understanding of clinical trial data requirements and presentation • Ability to communicate effectively with physicians, health care workers, study coordinators, and IRB/EC/REB personnel • Ability to prepare slides and present complex information professionally and clearly • SoCRA or ACRP certification preferred but not required • Ability to meet the physical demands of the role, including occasional lifting of up to 25 pounds • Extensive computer keyboard use • Ability to travel 20-30% as needed

🏖️ Benefits

• Compensation target of $115,000.00 • Travel as needed (typically between 20-30%) • Reasonable accommodations for individuals with disabilities • Equal employment opportunity • Pre-employment background and drug screen processes aligned to local, state and federal laws