Clinical Study Manager

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $68.8k - $133.7k / 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, coordinating team and client reviews • Create and manage study tracking tools, metrics, systems, and reporting • Support protocol training, client and site management, oversight, 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 resolve cross-functional action items • Drive site activities from start-up through close-out, including site selection, submissions, document collection, negotiations, initiation, enrollment, monitoring, communications, and close-out • Monitor site data quality, protocol and regulatory compliance, adverse events, and protocol deviations • Maintain investigator site files and ensure sites have required study materials • Develop recruitment and site engagement strategies • Ensure project plans and Trial Master File documents are current, consistent, audit-ready, and compliant • Assist with development, testing, and implementation of EDC, CTMS, TMF, and device accountability systems • Work with data management and biostatistics to develop reports, review data, and identify trends • Assist with clinical deliverables for regulatory submissions and develop clinical study reports • Ensure adherence to contractual agreements, department guidelines, SOPs, regulations, and ICH Guidelines • 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 site and sponsor clinical audits and FDA/competent authority inspections • Organize and manage Investigator Meetings • Select and manage Core Laboratories • Select and manage safety committees such as DSMBs or CECs

🎯 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, required • Knowledge of Good Clinical Practices • Knowledge of regulations that apply to medical device trials at various stages of development • Familiarity with the clinical trial process • Understanding of site escalation process for compliance issues • Multidiscipline therapeutic knowledge covering at least 2 therapeutic areas • Familiarity with medical device development process from pre-clinical to commercialization • Understanding of the role of data management and biostatistics in the clinical trial process • Understanding of the type and quality of data needed from a clinical trial and how it should be presented • Ability to effectively communicate with physicians, health care workers, study coordinators, and IRB/EC/REB personnel • Ability to prepare slides and present complex information professionally and clearly; strong speaking skills • SoCRA or ACRP certification preferred but not required • Ability to meet the stated physical demands, including occasional lifting/moving up to 25 pounds and extensive computer keyboard use • Willingness to travel as needed, typically 20–30%

🏖️ Benefits

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