Senior Clinical Data Manager

February 20

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Ora

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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.

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

201 - 500 employees

📋 Description

• Oversees and coordinates all data management activities in support of clinical and/or non-clinical research studies for study initiation, set up, maintenance, and close out. • Manages the day-to-day data management project activities including, but not limited to timelines, budgets, staff, project scope, reports and communication for the lifecycle of the project(s). • Mentors/trains Clinical Data Managers and Clinical Data Analysts. • Act as Lead Data Manager for one or more high complexity projects or programs, demonstrating independence and initiative to ensure project success. • Perform and oversee study setup including eCRF design, database structure development, document creation and/or approval, data entry screen and edit check testing and approval, data transfer agreements, etc. • Proactively plan, allocate and prioritize workloads for multiple projects (to include listings review, third party vendor imports, vendor and SAE reconciliation, query management tasks, and data deliverables, etc.). • Work independently to oversee day to day data management project activities. • Establish, monitor and maintain timeline for data management responsibilities. • Generate, send and track receipt of Training Forms for new database users; complete User Access Request Forms. • Mentor clinical data managers and clinical data associates.

🎯 Requirements

• Master’s degree (preferably in engineering, applied or life science) and at least four (4) years of experience in clinical data management including leading several clinical studies, or • Bachelor’s degree (preferably in engineering, applied or life science) or equivalent education and work experience with a minimum of five (5) years of experience in clinical trials, or • Current Certified Clinical Data Manager (CCDM) status and five (5) years of experience in clinical trials. • Exceptional working knowledge of clinical trials and the data management role in the clinical trials process. • Excellent organizational and project management skills. • Good knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations. • A minimum of 3 years staff mentoring and leadership experience. • Outstanding leadership capabilities. • Strong delegation abilities. • Highly effective written and verbal communication skills in English. • Technical skills with EDC systems, CDMS and other relational databases, and Microsoft Office products. • Desirable skills include: CRF design, MS Project, involvement with a federal submission (either NDA or PMA), programming skills (SAS, PL/SQL), analytical capabilities, medical coding (adverse events and medical therapies). • Experience in therapeutic areas (TAs) of ophthalmology in clinical trials is preferred.

🏖️ 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.