Senior Clinical Project Manager

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🕒 May 12

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Ora

201 - 500 employees

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, we have proudly helped our clients earn more than 85 product approvals. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. 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. We bring together the world's most extensive and experienced team of ophthalmic experts, R&D professionals, and management executives to maximize the value of new product initiatives.

📋 Description

• May manage department Clinical Project Managers, Assistant Project Managers, Clinical Trial Associates and other supporting staff. • Manages cross functional project teams derived from the groups within clinical development to deliver a high-quality clinical trial(s) in compliance with all regulations and SOPs. • Works with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects. • Reviews protocol, source documents and CRFs and tracks them to completion. • Responsible for creating and maintaining project timelines for each project and uses these timelines to track and manage a project’s progress. • Reviews study metrics for performance and quality with the team and management. • Prepares high-quality reports (financial, project, etc.) for management on program status and issues. • Ensures review of clinical electronic Trial Master File (eTMF) for completeness. • May represent Ora at professional meetings or seminars.

🎯 Requirements

• Bachelors’ 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. • Ophthalmology experience preferred. • Understanding of multi-center drug and/or device trials. • Experience with Veeva TMF and CTMS systems. • Proficiency with Excel, PowerPoint and vendor management.

🏖️ Benefits

• Competitive salaries along with a structured pension plan. • Offering private medical insurance healthcare beginning day 1 provided by Vitality and SimplyHealth. • Offering peace of mind through Canada Life to help you and your family feel secure. • 25 days of annual leave + Birthday PTO + bank holidays. • We'll reimburse you to support your remote workspace and wellness purchases. • 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.

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