Senior Director, Clinical Data Management

2 days ago

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Description

• Oversees and manages some aspects of data management operations related to the assigned team structure including staffing and staff development, oversight of management team members, project resource planning/loading, project management, leading/supporting implementation of strategies to improve efficiencies, sponsor support, and assuring quality work execution and output. • Actively participates in business development and strategic planning. • Applies a high level of technical expertise and professional experience to effectively lead data management and clinical programming staff and to develop solution alternatives to problems. • Keeps Executive Management apprised of data management project status. • Maintains performance metrics that are adequately analyzed for trends, root cause(s) and corrective action(s).

Requirements

• Bachelor’s degree in applied or life science and minimum of 12 years of experience in clinical trials (with at least 8 years leading a large team in data management) or equivalent education and work experience. Direct leadership of a large team is required. • Extensive experience in clinical data management preferably within a CRO environment • Successful record of accomplishment in establishing, directing, and overseeing data management operations division/department • Demonstrated ability to successfully manage compressed study timelines and staff/team members and in accordance with applicable regulations • Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Part 11 • Project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills • Effective leadership, budget forecast and implementation skills • Skills including programming and medical coding (adverse events, medical history, and medical therapies) are a plus • CDISC, CDASH/SDTM training and experience • EDC experience (Medidata Rave and iMedNet are a plus) • Experience in multiple therapeutic areas (TAs) in clinical trials including experience in at least two of the following TAs: ophthalmology, oncology, cardiology, central nervous system (CNS), infectious disease, respiratory, endocrinology, gastroenterology

Benefits

• Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1. • Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays. • Financial: Competitive salaries along with a 401K plan through Fidelity with company match. • Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave. • Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure. • Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases. • Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family. • Career Development Opportunities: Continued opportunities to grow and develop your career journey. • Global Team: Opportunities to work with colleagues across the globe. • Impact: A chance to research new ophthalmic therapies that will impact patients across the globe.