[Hiring] Clinical Operations Manager @Ora

Role Description

The Clinical Operations Manager is a key operational leader within the Clinical Monitoring organization, responsible for overseeing and optimizing Clinical Trial Associate (CTA) support activities across Ora clinical studies. This role serves as a liaison between CTA teams, CRAs, Project Managers and Clinical Operations leadership to ensure efficient, compliant and high-quality trial execution.

The role provides operational leadership, mentorship, training, process oversight, resource coordination and continuous improvement support for CTA activities while driving operational excellence and inspection readiness.

What You’ll Do:

• Clinical Trial Associate Operational Leadership
  • Serve as the operational lead and subject matter expert for CTA functions within the Clinical Monitoring organization.
  • Partner with Leadership to implement operational strategies, departmental objectives and process improvements.
  • Oversee resource forecasting and workload assessments for the CTA group.
  • Provide functional leadership, guidance, mentoring and day-to-day support to CTA staff.
  • Support onboarding, training and professional development initiatives for CTAs.
  • Approve time reporting and expenses for direct reports.
  • Act as an escalation point for CTA operational issues and collaborate with Monitoring leadership to resolve challenges.
• Monitoring Operations Support
  • Partner with Project Managers, CTMs and CRAs to ensure CTA activities support project plans and study timelines.
  • Monitor CTA-related performance metrics and operational indicators.
  • Support inspection readiness and audit preparedness activities.
  • Provide operational oversight of CTA deliverables to ensure quality and compliance.
• Process Excellence and Continuous Improvement
  • Lead initiatives focused on standardization, optimization, automation and continuous improvement.
  • Support development and maintenance of SOPs, work instructions, training materials and operational tools.
  • Promote effective utilization of CTMS, eTMF and other clinical technologies.
  • Identify operational risks and recommend solutions.
• Study Oversight and Compliance
  • Oversee CTA support activities related to study startup, maintenance and closeout.
  • Ensure study documentation and TMF activities remain complete and inspection-ready.
  • Support compliance with sponsor requirements, SOPs, ICH-GCP guidelines and regulations.
• Additional Responsibilities
  • Occasionally assist study projects where additional oversight of more junior team members is needed, or there is a need for more resources.
  • Responsibilities may differ slightly from the above based on specific needs of the business.
  • Clear and sustained demonstration of the Ora Clinical’s Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.

Qualifications

• Bachelor’s degree with 5 years’ experience as a clinical research experience or equivalent combination of education, training and experience.
• Minimum of 1 year of management or leadership experience, preferably in a CRO setting.

Requirements

• Extensive clinical operations experience in clinical trials specifically following Ora processes, and utilizing Ora standard tools such as Veeva Vault document management system (eTMF and CTMS), ICH GCP, DIA TMF Reference Model and regulatory guidelines/directives is strongly preferred.
• Proven ability to lead multifunctional teams and manage and mentor junior clinical operations staff.
• Prior CRO experience is strongly preferred.
• Ability to motivate and lead / mentor a team and identify and execution coaching opportunities.
• Understanding of comprehensive regulatory requirements and implications for clinical operations.
• Experience managing external partnerships and relations (e.g., sites, vendors, sponsors).
• Detailed knowledge of regulatory requirements and ICH/GCP guidelines to support clinical trial documentation needs and records management.
• Extensive clinical operations experience in ophthalmology clinical trials.
• Demonstrated ability to work independently, take initiative, complete tasks to deadlines.
• Ability to communicate effectively with internal team and, when necessary, sponsors and external vendors, including issue escalation, training and responding to inquiries and concerns.

Benefits

• Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.
• Competitive salaries along with a 401K plan through Fidelity with company match.
• Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.
• Offering peace of mind to help you and your family feel secure.
• We'll reimburse you to support your remote workspace and wellness purchases.
• No matter what issues you're facing, New Directions is here to help you and your family.
• Continued opportunities to grow and develop your career journey.
• Opportunities to work with colleagues across the globe.
• A chance to research new ophthalmic therapies that will impact patients across the globe.