(Senior) Clinical Trials Regulatory Manager
4 semanas atrás
PURPOSE
Manages complex regulatory projects and programs and supports more junior members of the team.
RESPONSIBILITIES
Acts as a Clinical Trials Regulatory Manager (CTRM) on complex clinical trial projects/programs and may act as a Regulatory Oversight for a key customer. May act as a Project Manager on stand-alone projects Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers May strategically plan and perform European centralized submissions and facilitate global submissions for complex studies and programs Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, clinical trial justifications May design training materials and deliver training externally and internally. Anticipates potential challenges that could impact the trial and develop strategies to optimize the delivery Provides mentorship to junior colleagues and engage in department knowledge sharing Supports key regulatory business development opportunities including proposal input and presentation to clients May perform additional tasks as deemed appropriate by Line ManagerREQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Good understanding of the regulations, directives and guidance supporting clinical Research and Development Extensive experience in regulatory and/or technical writing Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers Strong ownership and oversight skills Ability to earn respect from peers in other operational groups Advanced ability in establishing and maintaining effective working relationships with co-workers, managers and clients Innovative and solutions-driven Strong software and computer skills, including MS Office applications Sets a positive example to more junior colleagues relating to a professional manner, positive attitude and communication style with customers and colleagues May take calculated risks when making decisions, seeking guidance from Regulatory management, as appropriate; demonstrates autonomy and initiative, as appropriateMINIMUM REQUIRED EDUCATION AND EXPERIENCE
Degree in life science-related discipline or professional equivalent plus at least 6 years relevant experience* including 4 years regulatory experience or high school diploma plus 10 years relevant experience* including 6 years regulatory experience (*or combination of education, training and experience)IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at
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