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Syneos Health
Syneos Health
H1B vizos rėmėjasKonsultavimasLogistikaSveikatos priežiūra
„Syneos Health“ yra visiškai integruota biofarmacijos sprendimų organizacija, padedanti klientams perkelti gydymo būdus iš klinikinio kūrimo į komercinį tiekimą. Jos komandos derina klinikinę veiklą, medicinos reikalų valdymą, komercines žinias, technologijas ir rinkos įžvalgas, kad atlieptų kintančius sveikatos priežiūros poreikius ir padėtų kurti bei visame pasaulyje pristatyti svarbius gydymo būdus.
LinkedIn
Darbai įmonėje

Clinical Trial Manager in Mexico

Lead site qualification, monitoring, compliance, and close-out activities for Syneos Health’s biopharmaceutical research programs in Mexico. Support data integrity, participant recruitment, audit readiness, and delivery against trial timelines.

MXMeksikaHibridinisVisas etatasVidutinis lygisVyresnysis specialistasPrivaloma Kalba: anglųKlinikiniai tyrimai
Google Cloud Platform

Aprašymas

  • Conduct site qualification, initiation, interim monitoring, management, and close-out visits either on-site or remotely
  • Maintain compliance with regulatory requirements, ICH-GCP/GPP standards, and study protocols
  • Assess site and staff performance and recommend actions tailored to individual sites
  • Escalate significant issues, communicate their impact, and create corrective action plans
  • Confirm proper informed consent procedures and safeguard participant confidentiality
  • Monitor participant safety, clinical data quality, protocol deviations or violations, and pharmacovigilance concerns
  • Review source documents and confirm that clinical data is accurate and complete
  • Address site queries remotely and during visits within established timelines
  • Use designated hardware and software to review and capture clinical project data
  • Confirm adherence to electronic data capture procedures
  • Oversee investigational product inventory, reconciliation, storage, dispensing, administration, and labeling when applicable
  • Review Investigator Site Files and reconcile their contents with the Trial Master File
  • Record study activities in confirmation and follow-up letters, trip reports, communication logs, and other project documentation
  • Contribute to participant recruitment, retention, and study awareness initiatives
  • Monitor observations, site status, and action items through resolution
  • Coordinate site-level activities and communications in line with project objectives, deliverables, and timelines
  • Serve as the primary contact for site personnel or work in partnership with CRAs and CMAs
  • Confirm that assigned sites and project-specific team members complete required training and remain compliant
  • Participate in investigator, sponsor, global project, and clinical training meetings
  • Help maintain audit readiness and complete audit follow-up activities
  • For Real World Late Phase studies, support sites throughout the study lifecycle, conduct chart abstraction and data collection, and coordinate with sponsor affiliates, medical science liaisons, and local country teams

Reikalavimai

  • Bachelor’s degree, registered nurse qualification, or an equivalent combination of relevant education, training, and experience
  • Working knowledge of Good Clinical Practice, ICH Guidelines, and applicable regulatory requirements
  • Strong computer skills and willingness to adopt new technologies
  • Excellent communication, presentation, and interpersonal abilities
  • Availability for regular travel of up to 75%
  • For Real World Late Phase studies, familiarity with local requirements for real-world study designs
  • For Real World Late Phase studies, experience with chart abstraction and data collection

Privalumai

  • Opportunities for career growth and advancement
  • Supportive, involved line management
  • Training in technical and therapeutic areas
  • Recognition from peers
  • Total rewards program
  • Total Self culture
  • Workplace culture centered on diversity, belonging, and inclusion

Susiję darbai

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