Clinical Study Manager
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Job Description
Clinical Study Manager leading medical-device clinical trials at NAMSA, a global MedTech development solutions provider. Managing sites, study deliverables, compliance, and cross-functional teams.
Responsibilities:
- 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
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