Clinical Trial Manager β Regulatory Submissions
Posted Oct 7
Posted Oct 7
This is a fully remote position, open to applicants in United Kingdom.
β’ Lead the development and submission of critical documents necessary for regulatory approvals and site activation.
β’ Collaborate with project management, clinical operations, and regulatory affairs to optimize study start-up processes.
β’ Supervise the identification and selection of clinical sites, ensuring adherence to project criteria and compliance standards.
β’ Offer guidance and support to study teams and sites throughout the start-up phase.
β’ Keep abreast of industry regulations and trends to improve start-up strategies and best practices.
β’ Coordinate the delivery of site start-up and activation, addressing issues and enhancing team capabilities.
β’ Bachelor's degree in a relevant scientific discipline or a healthcare-related field.
β’ Significant experience in study start-up activities within the clinical research sector, with a solid understanding of regulatory requirements.
β’ Demonstrated ability to manage multiple projects and prioritize tasks effectively in a dynamic environment.
β’ Exceptional organizational skills and attention to detail, with a dedication to producing high-quality results.
β’ Strong communication and interpersonal abilities, facilitating effective collaboration with diverse teams and external stakeholders.
β’ A commitment to upholding high standards of quality and compliance in all study start-up activities.
β’ Willingness to travel as necessary (approximately 15%).
β’ Legal authorization to work in the country where the position is located.
β’ Competitive base salary along with performance-related incentives.
β’ Health and wellness programs, including medical, dental, and vision coverage where applicable.
β’ Retirement and pension plans.
β’ Life assurance and disability coverage.
β’ Employee assistance programs and wellness resources.
β’ Opportunities for learning and development through structured training and career pathways.
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