NAMSA
NAMSA
NAMSA tibbiy qurilmalar va in vitro diagnostika mahsulotlarini ishlab chiqaruvchilarga sinov, tadqiqot va konsalting xizmatlarini taqdim etadi. 1967-yilda tashkil etilgan kompaniya klinikagacha va klinik tadqiqotlar, laboratoriya sinovlari, shuningdek, tartibga solish va bozor strategiyasi bo‘yicha konsalting orqali mahsulotlarni dastlabki g‘oyadan tijoratlashtirishgacha bo‘lgan jarayonda qo‘llab-quvvatlaydi. 1 400 dan ortiq mutaxassisdan iborat jamoasi Shimoliy Amerika, Yevropa va Osiyodagi obyektlarda faoliyat yuritib, mijozlarga qurilmalarning xavfsizligi, samaradorligi va talablar bilan muvofiqligini baholashda yordam beradi.

Clinical Study Manager — Remote, United States

Lead multidisciplinary medical device studies for NAMSA, a global MedTech development services company. Oversee sites, regulatory deliverables, data quality, clinical reporting, and study execution.

Tavsif

  • Build and maintain core clinical study materials and operational tools
  • Coordinate review cycles with internal teams and clients
  • Develop and manage study trackers, metrics, systems, and reports
  • Support protocol training, client and site management, and escalation of site issues through resolution
  • Set project metrics and monitor delivery against project commitments
  • Provide regular project status updates to clients and internal stakeholders
  • Lead team and sponsor meetings and close out action items
  • Manage site activities from start-up through close-out, including selection, qualification, submissions, document collection, contracting, initiation, enrollment, monitoring, engagement, and closure
  • Monitor data quality, site compliance, adverse events, protocol deviations, and site communications
  • Resolve site and team issues and implement CAPAs when appropriate
  • Manage project deliverables and keep project plans and TMF-level documents current and consistent
  • Maintain Trial Master File quality and audit readiness
  • Support the development, testing, and implementation of EDC, CTMS, TMF, and device-accountability systems
  • Partner with data management and biostatistics on reports, listings, and data-trend reviews
  • Support clinical deliverables for regulatory submissions
  • Prepare clinical study reports
  • Maintain compliance with contracts, SOPs, ICH Guidelines, and applicable regulations
  • Lead multidisciplinary clinical projects ranging from simple to moderately complex studies
  • Manage cross-functional teams and working groups
  • Apply knowledge of investigational products and the medical device development process
  • Review monitoring reports
  • Conduct and summarize literature searches
  • Support clinical audits, regulatory inspections, and sponsor or vendor audits
  • Plan and manage Investigator Meetings
  • Select and manage Core Laboratories
  • Select and manage safety committees, including DSMBs or CECs

Talablar

  • Bachelor’s degree or equivalent experience in a related discipline
  • At least three years of relevant clinical trial or monitoring experience
  • Experience in project management
  • Fluency in English and the local language when different
  • Working knowledge of Good Clinical Practices
  • Knowledge of regulations governing medical device trials across development stages
  • Familiarity with clinical trial operations
  • Understanding of site escalation procedures for compliance concerns
  • Therapeutic knowledge spanning at least two disciplines
  • Familiarity with medical device development from preclinical work through commercialization
  • Understanding of clinical trial data management and biostatistics
  • Understanding of clinical trial data requirements and presentation
  • Ability to communicate effectively with physicians, healthcare professionals, study coordinators, and IRB, EC, or REB personnel
  • Ability to create presentation materials and explain complex information clearly and professionally
  • SoCRA or ACRP certification is preferred but not required
  • Ability to meet the role’s physical requirements, including occasional lifting of up to 25 pounds
  • Frequent computer keyboard use
  • Ability to travel 20–30% as needed

Imtiyozlar

  • Target compensation of $115,000.00
  • Travel as required, typically 20–30%
  • Reasonable accommodations are available for individuals with disabilities
  • Equal employment opportunity
  • Pre-employment background checks and drug screening conducted in accordance with applicable local, state, and federal laws

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