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Ora
Ora
201 – 500 Angajați
Sponsor pentru viza H1BConsultanțăIndustria prelucrătoareLogistică
Ora este o companie care oferă servicii complete pentru dezvoltarea medicamentelor și dispozitivelor oftalmologice, sprijinind inovatorii de la companii aflate în stadii incipiente până la organizații globale din domeniul farmaceutic și al dispozitivelor medicale. De peste 45 de ani, echipele sale au contribuit la dezvoltarea produselor oftalmologice prin dezvoltare preclinică și clinică, soluții integrate pentru date clinice, metodologii specializate și strategie globală de reglementare. Ora reunește experți în oftalmologie, profesioniști în cercetare și dezvoltare și lideri cu experiență în proiecte desfășurate din birourile sale internaționale din Statele Unite, Regatul Unit, Australia și Asia. Activitatea sa se concentrează pe sprijinirea clienților în dezvoltarea unor produse noi pentru îngrijirea vederii și în valorificarea la maximum a potențialului inițiativelor lor de produs.
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Locurile de muncă ale companiei

Clinical Operations Manager - Ora (United States Remote)

Lead Clinical Trial Associate operations at Ora, an ophthalmic drug and device development company. Drive compliant trial execution, inspection readiness, team performance, and continuous process improvement.

USStatele Unite ale AmericiiRemoteNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăOperațiuni clinice
Google Cloud PlatformVault

Descriere

  • Lead Clinical Trial Associate operations and serve as the subject matter expert within Clinical Monitoring
  • Work with leadership to execute operational strategies, department goals, and process improvements
  • Forecast resources and assess workloads across the CTA team
  • Provide functional leadership, mentoring, guidance, and daily support to CTA staff
  • Support CTA onboarding, training, and career development
  • Review and approve time records and expenses for direct reports
  • Escalate and resolve CTA operational matters with Monitoring leadership
  • Coordinate with Project Managers, CTMs, and CRAs to align CTA work with study plans and timelines
  • Track CTA performance measures and operational metrics
  • Contribute to inspection readiness and audit preparation
  • Oversee CTA deliverables to support quality and compliance
  • Lead standardization, optimization, automation, and continuous improvement efforts
  • Help create and maintain SOPs, work instructions, training content, and operational tools
  • Encourage effective adoption of CTMS, eTMF, and other clinical systems
  • Assess operational risks and recommend corrective solutions
  • Oversee CTA support across study startup, maintenance, and closeout
  • Ensure study records and TMF activities are complete and ready for inspection
  • Support adherence to sponsor requirements, SOPs, ICH-GCP, and applicable regulations
  • Provide additional project support when junior staff oversight or extra resources are needed

Cerințe

  • Bachelor’s degree and five years of clinical research experience, or an equivalent combination of education, training, and experience; relevant experience may substitute for education
  • At least one year of management or leadership experience, ideally in a CRO environment
  • Strong clinical operations experience, preferably with Ora processes and tools including Veeva Vault eTMF and CTMS, ICH-GCP, the DIA TMF Reference Model, and regulatory guidance
  • Demonstrated experience leading cross-functional teams and mentoring junior clinical operations staff
  • Previous CRO experience is strongly preferred
  • Ability to motivate, lead, and mentor team members while identifying coaching opportunities
  • Working knowledge of regulatory requirements and their impact on clinical operations
  • Experience managing relationships with sites, vendors, sponsors, and other external partners
  • Detailed understanding of clinical trial documentation, records management, and ICH-GCP requirements
  • Extensive experience supporting ophthalmology clinical trials
  • Ability to work independently, take initiative, and deliver work on schedule
  • Strong communication skills for collaborating with internal teams, sponsors, and vendors, including escalation, training, and issue response
  • Ability to set objectives, build structure, and maintain a focused, collaborative approach to high-quality work

Beneficii

  • Medical, dental, and vision coverage available from the first day
  • Flexible paid time off
  • Unlimited sick leave
  • 14 company-paid holidays
  • Fidelity 401(k) plan with company matching
  • Adoption assistance
  • Fertility assistance
  • 16 weeks of paid parental leave
  • Company-paid life insurance
  • Company-paid disability insurance
  • Remote workspace reimbursement
  • Wellness reimbursement
  • Employee Assistance Program
  • Career development opportunities
  • Collaboration with colleagues around the world

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