Senior Director - Monitoring

2 days ago

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Ora

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Allergy • Dry Eye • Retina • Anti-Infective • Anti-Inflammatory

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Description

• The Senior Director Monitoring Services is responsible for assisting with the planning, resourcing, and the execution of Ora's monitoring activities. • This individual provides strategic oversight and operational leadership with a focus on the development and maintenance of accurate operational plans including department and project timelines as well as budgets. • In collaboration across the organization, this individual will be responsible for planning, launching and strategies for growth, and new approaches to monitoring clinical trials such as Risk Based Monitoring. • The Senior Director will develop and revise robust training, onboarding and site management programs. • This individual must have the ability to balance multiple variables associated with this highly collaborative, matrixed role. • This individual will supervise and mentor a team of monitoring managers across the United States and support harmonization of global processes.

Requirements

• Bachelor's Degree in a life science related field or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities. • Thorough knowledge of and experience in risk-based monitoring principles including adherence to ICHE6R2 requirements in monitoring plan development and deployment. • Experience managing globally for trial and project delivery. • Significant clinical research experience (comparable to 12+ years) including at least 5 years’ experience in risk-based models including remote and clinical monitoring. • Line management experience appropriate to the size and complexity of the clinical management group globally. • Valid Driver's License and Passport. • Travel is estimated at 25%.

Benefits

• Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1. • Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays. • Competitive salaries along with a 401K plan through Fidelity with company match. • Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave. • Offering peace of mind to help you and your family feel secure. • We'll reimburse you to support your remote workspace and wellness purchases. • No matter what issues you're facing, New Directions is here to help you and your family. • 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.