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NAMSA
NAMSA
1,001 – 5,000 कर्मचारी
लॉजिस्टिक्सविनिर्माणस्वास्थ्य सेवा
NAMSA चिकित्सा उपकरणों और इन विट्रो डायग्नोस्टिक निर्माताओं के लिए परीक्षण, अनुसंधान और परामर्श सेवाएँ प्रदान करती है। 1967 में स्थापित यह कंपनी प्रीक्लिनिकल और क्लिनिकल अनुसंधान, प्रयोगशाला परीक्षण तथा नियामक और बाज़ार रणनीति परामर्श के माध्यम से शुरुआती अवधारणा से लेकर व्यावसायीकरण तक उत्पाद विकास में सहायता करती है। इसके 1,400 से अधिक विशेषज्ञों की टीम उत्तर अमेरिका, यूरोप और एशिया स्थित सुविधाओं में कार्य करती है और ग्राहकों को उपकरणों की सुरक्षा, प्रभावशीलता और अनुपालन का आकलन करने में मदद करती है।
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कंपनी की नौकरियाँ

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.

USसंयुक्त राज्य
$83,500 – $1,62,900 / वर्ष
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विवरण

  • 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

आवश्यकताएँ

  • 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

लाभ

  • 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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