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Ora
Ora
201 – 500 Employees
H1B Visa SponsorConsultingLogisticsManufacturing
Ora is a full-service ophthalmic drug and device development firm supporting innovators from early-stage companies to global pharmaceutical and medical device organizations. For more than 45 years, its teams have helped advance ophthalmic products through preclinical and clinical development, integrated clinical data solutions, specialized methodologies, and global regulatory strategy. Ora brings together ophthalmic experts, research and development professionals, and experienced leaders across projects delivered from its international offices in the United States, United Kingdom, Australia, and Asia. Its work is focused on helping clients develop new vision-care products and maximize the potential of their product initiatives.
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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.

USUnited StatesRemoteFull-timeMiddleSeniorEnglish RequiredClinical Operations
Google Cloud PlatformVault

Description

  • 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

Requirements

  • 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

Benefits

  • 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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