Clinical Operations Manager

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Ora

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏭 Manufacturing

💼 Consulting

📦 Logistics

Manufacturing • Consulting • Logistics

Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 45 years, Ora has helped clients earn more than 85 product approvals, supporting a wide array of organizations from start-ups to global pharmaceutical and device companies. Their offerings include pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies, all refined through thousands of global projects. Ora boasts an extensive and experienced team of ophthalmic experts, R&D professionals, and management executives to maximize the value of new product initiatives.

📋 Description

• Serve as the operational lead and subject matter expert for Clinical Trial Associate functions within Clinical Monitoring • 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 CTA onboarding, training, and professional development • Approve time reporting and expenses for direct reports • Escalate and resolve CTA operational issues with Monitoring leadership • Partner with Project Managers, CTMs, and CRAs to align CTA activities with project plans and study timelines • Monitor CTA performance metrics and operational indicators • Support inspection readiness and audit preparedness • Provide operational oversight of CTA deliverables for quality and compliance • Lead standardization, optimization, automation, and continuous improvement initiatives • Support development and maintenance of SOPs, work instructions, training materials, and operational tools • Promote effective use of CTMS, eTMF, and other clinical technologies • Identify operational risks and recommend solutions • Oversee CTA support for study startup, maintenance, and closeout • Ensure study documentation and TMF activities are complete and inspection-ready • Support compliance with sponsor requirements, SOPs, ICH-GCP guidelines, and regulations • Occasionally assist study projects requiring additional oversight of junior team members or additional resources

🎯 Requirements

• Bachelor’s degree with 5 years’ 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 • Extensive clinical operations experience in clinical trials, particularly using Ora processes and tools such as Veeva Vault 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 or mentor a team and identify and execute coaching opportunities • Understanding of comprehensive regulatory requirements and implications for clinical operations • Experience managing external partnerships and relations, including sites, vendors, and sponsors • Detailed knowledge of regulatory requirements and ICH/GCP guidelines for clinical trial documentation and records management • Extensive clinical operations experience in ophthalmology clinical trials • Demonstrated ability to work independently, take initiative, and complete tasks to deadlines • Ability to communicate effectively with internal teams, sponsors, and external vendors, including issue escalation, training, and responding to inquiries and concerns • Ability to set goals, create structure, and maintain a focused and collaborative approach to timely, high-quality work

🏖️ Benefits

• Comprehensive medical, dental, and vision healthcare options beginning day 1 • Flexible PTO • Unlimited sick time • 14 company-paid holidays • 401(k) plan through Fidelity with company match • Adoption assistance • Fertility assistance • 16 weeks paid parental leave • Company-paid life insurance • Company-paid disability insurance • Remote workspace reimbursement • Wellness reimbursement • Employee Assistance Program • Career development opportunities • Opportunities to work with colleagues across the globe