Senior Director - Clinical Data Operations

October 14

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Clario

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Cardiac Solutions • Medical Imaging • eCOA • Respiratory Solutions • Precision Motion

1001 - 5000

💰 Private Equity Round on 2019-10

Description

• The Director, Clinical Data Operations is responsible for shaping, directing and leading all Data Management activities including Data Programming and Data Analytics/Data Science across the Digital Physiology business unit. • The position will lead and retain a global team to ensure optimal performance and on-time, high quality study delivery for our clients. • Will identify and lead initiatives (workstreams) aimed at transformative change for data collection, analysis, reporting and visualization for the organization resulting in driving operational excellence, lower cost, and improving overall staff / sponsor satisfaction and engagement. • Establish and drive global data management, data programming and data science strategy related to resourcing, technologies and processes to maximize efficiency, innovation and data quality. • Conduct Analytical Deep-Dives: Perform in-depth analyses to proactively identify product opportunities, inform experimentation, and shape product roadmaps. • Offer expert guidance and oversight on clinical data management practices. • Actively partner with the Commercial teams to ensure there is awareness and alignment of capabilities and offerings, Go to Market strategies are supported and reflected in our approach to service delivery, assist in bid defenses and strategic opportunity planning, product positioning and pricing and executive governance for key customer accounts. • Develop a ‘Quality First’ culture that ensures all services are delivered in a manner that is consistent with industry best practices and regulatory requirements, including ensuring the effective remediation of quality issues as and when they occur. • Increase customer satisfaction and overall profitability through improved execution of implementations. • Improve the company's competitive position through improved execution, efficiency, and productivity. • Motivate, coach, and lead a high performing, geographically dispersed team fostering a community of excellence, accountability, and continuous learning.

Requirements

• 10+ years’ leadership experience in SAS Programming/data management required, including data import, data cleaning, and custom report generation. • 10+ years clinical trials experience within a CRO or pharmaceutical research organization. • Understanding of medical and/or clinical trial terminology required. • Proven ability in analyzing data. • Experience managing global teams. • Working knowledge of GCP, ICH guidelines and FDA regulations. • Working knowledge of other clinical trial data management tools such as Oracle Clinical, etc. • Experience working with computer software including Word, Excel and Access preferred. • Experience with SDTM model a plus. • Strong interpersonal and communication skills, both verbal and written. • Strong organizational and leadership skills. • Goal oriented. • Ability to promote and maintain a positive and professional and positive attitude.