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Syneos Health
Syneos Health
Sponsor pentru viza H1BAsistență medicalăConsultanțăLogistică
Syneos Health este o organizație complet integrată de soluții biofarmaceutice, care ajută clienții să ducă terapiile de la dezvoltarea clinică până la furnizarea comercială. Echipele sale combină expertiza clinică, afacerile medicale, activitățile comerciale, tehnologia și informațiile despre piață pentru a răspunde nevoilor în schimbare din domeniul sănătății și pentru a sprijini dezvoltarea și lansarea unor tratamente importante în întreaga lume.
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Locurile de muncă ale companiei

Clinical Trial Manager I, Sponsor-Dedicated (Remote Greece)

Manage clinical monitoring and site activities for Syneos Health’s biopharmaceutical solutions business. Support regulatory compliance, data integrity, patient recruitment, and timely trial delivery.

GRGreciaRemoteNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăCercetare clinică

Descriere

  • Conduct site qualification, initiation, interim monitoring, management, and close-out visits either remotely or on site
  • Assess site and staff performance and recommend site-specific improvements
  • Escalate significant issues and create action plans with project team direction
  • Confirm informed consent, participant confidentiality, safety, and clinical data integrity requirements are met
  • Evaluate site procedures against Clinical Monitoring and Site Management Plans
  • Review source documents and confirm clinical data recorded in case report forms
  • Resolve site queries remotely or on site within agreed timelines
  • Use designated hardware and software to review and capture clinical project data
  • Confirm compliance with electronic data capture requirements
  • Oversee investigational product inventory, reconciliation, storage, dispensing, administration, and associated records
  • Review Investigator Site Files and reconcile them against Trial Master Files
  • Record monitoring work in letters, trip reports, communication logs, and other project documentation
  • Contribute to participant recruitment, retention, and study awareness activities
  • Monitor observations, site status, and action items through resolution
  • Coordinate site-level activities and communications to achieve project objectives, deliverables, and timelines
  • Collaborate with site personnel, CRAs, and Central Monitoring Associates
  • Confirm assigned sites and team members receive required training and maintain compliance
  • Participate in investigator, sponsor, global monitoring, and clinical training meetings
  • Support audit readiness, preparation, and follow-up activities
  • For Real World Late Phase studies, support sites throughout the study, perform chart abstraction and data collection, and work with sponsor affiliates, medical science liaisons, and local country teams

Cerințe

  • Bachelor’s degree or RN qualification in a related field, or an equivalent combination of 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
  • Willingness and ability to travel regularly for up to 75% of the role
  • Ability to perform clinical monitoring and site management activities remotely and on site
  • Knowledge of local requirements for Real World Late Phase study designs, where applicable

Beneficii

  • Opportunities for career development and progression
  • Supportive, engaged line management
  • Training in technical and therapeutic areas
  • Peer recognition programs
  • Total rewards program
  • Total Self culture
  • Diversity, inclusion, and belonging initiatives

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