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NAMSA
NAMSA
1.001 – 5.000 Angajați
Asistență medicalăIndustria prelucrătoareLogistică
NAMSA oferă servicii de testare, cercetare și consultanță producătorilor de dispozitive medicale și dispozitive pentru diagnostic in vitro. Înființată în 1967, compania sprijină dezvoltarea produselor de la conceptul inițial până la comercializare, prin cercetare preclinică și clinică, teste de laborator și consultanță privind strategiile de reglementare și de piață. Echipa sa, formată din peste 1.400 de specialiști, lucrează în unități din America de Nord, Europa și Asia pentru a ajuta clienții să evalueze siguranța, eficacitatea și conformitatea dispozitivelor.
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Locurile de muncă ale companiei

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.

USStatele Unite ale Americii
83.500 $ – 162.900 $ / an
RemoteNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăCercetare clinică

Descriere

  • 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

Cerințe

  • 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

Beneficii

  • 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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