CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com

Job Summary:

The position is accountable for the effective and efficient execution of clinical studies in the US and potentially EU in accordance with regulatory requirements and CooperVision internal procedures, including clinical studies for registration purpose, and other types as required. Clinical evaluation activities may also be covered under this position.

Essential Functions & Accountabilities:

• Accountable for whole-process management of multiple multi-center clinical studies, including:

• Define project plans, identify critical project success factors for tracking, analysis and reporting, establish project reporting schedule, perform project updates on timely manner and conduct project management including timeline, budget, compliance, quality, etc.
• Drive and provide strong inputs to the development of clinical study dossiers including but not limited to clinical protocol, Case Report Form (CRF), Informed Consent Form (ICF), etc. with support from R&D.
• Build and maintain relations with external vendors (CRO, SMO, equipment vendors, etc.) and clinical sites/investigators.
• Host clinical study meetings with clinical sites/investigators. Develop and deliver training and presentations.
• Support clinical trial filing to regulatory authorities
• Monitor and audit clinical study execution and support clinical study inspection as appropriate.
• Coordinate clinical study report generation and review.
• Take responsibility for addressing issues or roadblocks throughout the project.
• Drive study management and clinical operational excellence by identifying opportunities, mitigating risks and supporting continuous improvements.
• Establish and enforce departmental standard of procedures, tools for project management, etc.
• Assists with mentoring and oversite of clinical research associates

• As needed, review clinical evaluation of medical literature related to the CooperVision’s products, and provide evidence for product registration and continued marketing.

Qualifications

Knowledge, Skills and Abilities:

• Specialized knowledge of clinical operations and solid project management skills; able to integrate, harmonize and coordinate administrative, technical or managerial activities relative to planning, organizing, controlling and execution of clinical projects.
• Great communication and interpersonal skills, be able to manage external parties (CRO, SMO, clinical sites, etc.) and interact professionally in the medical environment.
• Excellent capability in solving complex problems proactively and independently under uncertain and evolving regulatory and complicated external stakeholder environment.
• Ability to learn product knowledge and highly technical materials, search and read clinical/medical literature and possess basic medical writing skills.
• Excellent written and spoken English.
• Strong teamwork spirit and ownerships with self-motivation to drive things forward.

Work Environment:

• General office environment
• Flexible hours to support the nature of the job.
• Occasional travel (<20%) to clinical sites or external vendors.

Experience:

• > 5 years’ experience in clinical operation/management in pharmaceutical or medical device industry.
• Experience in optometry/ophthalmology preferred.

Education:

• Bachelor’s degree, biological sciences or medical/scientific-related field (or equivalent experience) required.
• Master or doctoral degree in optometry/ophthalmology preferred

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