Director, Clinical Operations

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Glycomine Inc.

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💰 Series B on 2021-06

Description

• Oversee and manage all aspects of clinical operations for programs • Possesses clinical operations expertise with a track record of success • Manage a team internally, at clinical sites, and vendors • Provide strategic leadership and operational expertise to guide Clinical Development team • Collaborate across diverse functions to develop operational strategies • Ensure seamless execution of clinical trials • Oversee the planning, implementation, execution, and management of clinical studies • Thrive in a fast-paced, innovative environment while remaining flexible and proactive • Analyze complex issues to develop relevant and realistic plans and recommendations for implementation • Excellent matrix management skills, written and verbal communication skills, attention to detail, and knowledge of quality obligations

Requirements

• BA/BS preferably in a health-related field; preferred MA/MS degree with major in biological, life science, nursing or related field • 10 + years of experience in clinical operations management within the pharmaceutical or biotechnology industry • At least 7 years of experience in the biopharma or CRO industry is required • Demonstrated excellence in managing clinical trials and a solid understanding of the trial processes • Proven track record of success and a history of innovative program and trial execution to ensure study progress, timelines, data integrity, and compliance with health authority requirements • Domain expertise in drug development, with a preference for experience in early-stage clinical trials • Strong vendor and project management skills are critical • Strong and up-to-date knowledge of Good Clinical Practices and ICH Guidelines, including their application in the conduct of clinical trials • Expertise in global regulatory and compliance requirements for clinical research, including but not limited to, US CRF, EU CTD and ICH GC • Strong working knowledge of GCP/ICH and other applicable regulations/guidelines, required • Ability to manage multiple competing priorities and adapt to changes • Strong communication, interpersonal, and problem solving skills • Must be comfortable working in a fast-paced environment • East Coast time zone