Clinical Operations Manager

POSITION TITLE: Clinical Operations Manager

DEPARTMENT: Monitoring

Ora Values the Daily Practice of …

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

At Ora, we are building the future of ophthalmic clinical research. As the world’s leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.

The Role:

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.

What We Look For:

• Experience needed for the Role:
  •    Bachelor’s degree with 5 years’ experience as a clinical research experience or equivalent combination of education, training and experience. Years of experience may be considered in lieu of education
  • Minimum of 1 year of management or leadership experience, preferably in a CRO setting

• Additional Skills & Attributes:
  • 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.

• Competencies and Personal Traits:

• • What We Do:
    • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
  • How We Do It:
    • IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
    • Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
  • Why We Do It:
    • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.

What We Offer:

• Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.  
• Financial: Competitive salaries along with a 401K plan through Fidelity with company match. 
• Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave. 
• Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure. 
• Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases. 
• Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family. 
• Career Development Opportunities: Continued opportunities to grow and develop your career journey.  
• Global Team: Opportunities to work with colleagues across the globe. 
• Impact: A chance to research new ophthalmic therapies that will impact patients across the globe. 

Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.

Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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