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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, Project Management — Remote in Mexico

Clinical Trial Manager responsible for sponsor-dedicated monitoring, site oversight, project risk management, and clinical trial delivery at Syneos Health.

MXMexicRemoteNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • Oversee site management, clinical monitoring, and central monitoring activities while maintaining patient safety, protocol and GCP compliance, regulatory adherence, and data integrity.
  • Manage site activities from activation through closeout, including recruitment, investigator payments, and related operational tasks.
  • Identify critical data, process, and protocol-execution risks and develop mitigations through the RACT.
  • Review study scope, budgets, and protocols, and ensure project teams understand their contractual responsibilities.
  • Identify and escalate risks affecting timelines, quality, budgets, or contracted scope.
  • Participate in and present at key study meetings, including Kick Off Meetings.
  • Act as an escalation point for investigator-site communications and engage with investigators and site staff by phone or in person.
  • Partner with Study Start Up, Patient Recruitment, Data Management, and other functions to achieve study milestones.
  • Create and maintain clinical study tools and templates, including Clinical Monitoring Plans.
  • Ensure CTMS, dashboards, and related systems are configured and available, including user acceptance testing and access and audit-trail reviews.
  • Coordinate study-team training on protocols, CRF completion, dashboards, SOPs, clinical plans, data plans, and timelines.
  • Manage CRA and Central Monitor resourcing, site assignments, and study-team conduct.
  • Maintain the quality and visibility of clinical monitoring, central monitoring, and site management deliverables.
  • Review oversight dashboards and trial systems such as CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS, and central monitoring dashboards.
  • Monitor compliance with monitoring strategies, CMP/SMP requirements, and risk plans.
  • Review site and central monitoring documentation to ensure timely and compliant delivery.
  • Provide clients, project managers, and leaders with updates on deliverables and risks.
  • Support inspection readiness, corrective action plans, data cuts, and database-lock deadlines.
  • Oversee CRAs and Central Monitors, evaluate compliance, and identify emerging risks.
  • Give staff-performance feedback to line managers and support larger or more complex trials when needed.

Cerințe

  • Bachelor’s degree, RN qualification, or an equivalent combination of education, training, and experience in a related field.
  • Proven ability to lead and align teams toward project milestones.
  • Experience working effectively in an international environment.
  • Demonstrated expertise in clinical or central site management and monitoring.
  • Experience with risk-based monitoring is preferred.
  • Understanding of clinical trial financial principles and budget management.
  • Knowledge of Good Clinical Practice, ICH Guidelines, and other applicable regulatory requirements.
  • Proficiency with standard computer applications.
  • Strong communication, presentation, and interpersonal skills when working with project teams and sites.
  • Strong conflict-resolution capabilities.
  • Ability to use problem-solving techniques, resolve complex issues, and apply a risk-management approach.
  • Critical-thinking skills to identify root causes and determine appropriate solutions.
  • Willingness to travel moderately, approximately 20%.

Beneficii

  • Opportunities for career development and progression.
  • Supportive, engaged line management.
  • Technical and therapeutic-area training.
  • Peer-recognition programs.
  • Total rewards program.
  • Total Self culture focused on authenticity and inclusion.
  • Diversity, equity, and belonging initiatives.

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