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Syneos Health
Syneos Health
H1B Visa SponsorConsultingHealthcareLogistics
Syneos Health is a fully integrated biopharmaceutical solutions organization that helps clients move therapies from clinical development to commercial delivery. Its teams combine clinical, medical affairs, commercial, technology, and market insights to address changing healthcare needs and support the development and launch of important treatments worldwide.
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Clinical Trial Manager II – Regulatory Experience, Argentina Remote

Lead clinical trial site management, monitoring, regulatory compliance, and risk oversight for Syneos Health’s research programs. Coordinate international study teams, systems, and trial deliverables from activation through closeout.

ARArgentinaRemoteFull-timeMiddleSeniorEnglish RequiredClinical Research
Google Cloud Platform

Description

  • Oversee site management, clinical monitoring, and central monitoring activities with a focus on patient safety, protocol adherence, GCP and regulatory compliance, and data integrity.
  • Manage site relationships from activation through closeout, including patient recruitment activities and investigator payments.
  • Assess critical data, operational processes, protocol execution risks, and appropriate mitigation strategies.
  • Review study scope, budgets, and protocols, and communicate contractual responsibilities to clinical project teams.
  • Identify and escalate threats to timelines, quality, budgets, and contracted scope.
  • Design and implement risk mitigation actions.
  • Contribute to and present at major study meetings, including kick-off meetings.
  • Act as an escalation contact for investigator-site communications and collaborate with principal investigators and site personnel.
  • Coordinate delivery handoffs with Study Start-Up, Patient Recruitment, and Data Management teams.
  • Create and maintain clinical study tools and templates, including Clinical Monitoring Plans.
  • Confirm that CTMS, dashboards, and related systems are configured and operational, including user acceptance testing and access and audit-trail reviews.
  • Organize study-team training covering protocols, CRFs, dashboards, SOPs, 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 clinical trial platforms, including CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS, and central monitoring dashboards.
  • Monitor adherence to monitoring strategies, CMP/SMP requirements, and risk plans.
  • Review monitoring records and ensure revisions, approvals, and deliverables comply with company and sponsor requirements.
  • Collaborate with clients and functional teams while reporting on deliverable progress and risks.
  • Support inspection-readiness activities within the clinical trial management scope.
  • Supervise CRAs and Central Monitors, evaluate compliance and emerging risks, and support corrective action plans.
  • Help deliver study activities required to meet data-cut and database-lock deadlines.
  • Provide staff performance feedback to line managers.
  • Take responsibility for larger or more complex trials when assigned.

Requirements

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

Benefits

  • Opportunities for career growth and advancement.
  • Supportive, engaged line management.
  • Training in technical and therapeutic-area topics.
  • Peer recognition programs.
  • Total rewards program.
  • Inclusive workplace culture.
  • Reasonable accommodations where appropriate.

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