Senior Clinical Project Manager

🕒 April 20

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

🦅 H1B Visa Sponsor

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👻 Ghost score 45%

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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

• Manage cross-functional clinical project teams to deliver high-quality clinical trials in compliance with regulations and SOPs • Oversee Clinical Project Managers, Assistant Project Managers, Clinical Trial Associates and other supporting staff as needed • Coordinate clinical trial initiation, planning, execution, control, closure and resourcing • Serve as the operational focal point for interdepartmental and intradepartmental groups in a matrix environment • Review protocols, source documents and CRFs and track them to completion • Create and maintain project timelines • Create project plans, roles and responsibility tables, and communication plans • Conduct weekly project budget and progress reviews • Review study metrics for performance and quality • Prepare financial and project status reports for management • Ensure clinical eTMF completeness • Manage and coordinate clinical trial vendors, including central labs, IVRS and reading centers • Represent Ora at professional meetings or seminars as needed • Prepare new study budgets and proposal documents and participate in bid defenses • Participate in department and company-wide process improvement initiatives • Adhere to Ora’s quality system, data integrity, business ethics and regulatory requirements • Demonstrate Ora’s values and linked behaviors

🎯 Requirements

• Bachelor’s degree in Life Science with at least 7 years of clinical trial experience; years of experience may be considered in lieu of education • Minimum of 3 years of clinical project management experience • Understanding of multi-center drug and/or device trials • Experience with Veeva TMF and CTMS systems • Demonstrated expertise in applicable regulatory requirements and GCP • Proficiency with Excel, PowerPoint and vendor management • Ability to plan, identify risks, anticipate issues and outcomes, and respond strategically, tactically and operationally • Demonstrated leadership skills and ability to multitask and solve problems proactively • Highly effective organizational and communication skills • Ophthalmology experience preferred • Multi-lingual communication is a plus • Travel of up to 15% is required, mainly domestic and overnight

🏖️ 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