ASSOCIATE MANAGER, CLINICAL TRIALS REGULATORY MANAGEMENT (M/W/D) - HOME-BASED, EMEA
Descripción de la oferta de empleo
Independently provides regulatory support for more complex projects.
RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.
Prepares and maintains core clinical trial submission dossiers in accordance with applicable regulatory requirements.
Ability to write scientific documents e.
.
Investigational Medicinal Product Dossier, clinical trial justifications with minimum support of senior staff May strategically plan and perform European centralized submissions and facilitate global submissions May provide support on regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs) Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.
Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA).
Deliver regulatory training/presentations as required.
May perform additional tasks as deemed appropriate by Line Manager REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Good understanding of the regulations, directives and guidance supporting clinical Research and Development Demonstrates comprehensive regulatory/technical expertise Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach Strong ownership and oversight skills Demonstrated skills in chairing small meetings Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision Ability to establish and maintain effective working relationships with co-workers, managers and clients Strong software and computer skills, including MS Office applications MINIMUM REQUIRED EDUCATION AND EXPERIENCE Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience* or high school diploma plus at least 9 + years’ experience* (*or combination of education, training and experience) EU-CTR knowledge & experience Global CTA submissions experience PHYSICAL REQUIREMENTS Extensive use of telephone and face-to-face communication requiring accurate perception of speech Extensive use of keyboard requiring repetitive motion of fingers Regular sitting for extended periods of time Travel might be required This role is not available for UK visa sponsorship 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 https://jobs.
qvia.
om
Detalles de la oferta
- IQVIA
- En toda España
- Sin especificar - Sin especificar
- Sin especificar
- 01/09/2024
- 30/11/2024
Rfps, including consolidating costs and margins based on company guidelines excellent written and verbal communication skills... use their initiative to drive innovation and identify potential opportunities and risks within the accounts, contributing to the commercial management strategy achievement......
Multinational company is seeking an order management associate... good knowledge of office pack and most usual erp... responsive and reliable with an ability to work both independently and as a team player when successfully completing routine and urgent tasks... extremely organized and detail-oriented......
Proficiency in using customer relationship management (crm) tools and other relevant software... demonstrated expertise in the igaming industry, with a strong emphasis on vip player management... flexibility in terms of working hours, as vip player management may occasionally require evening and weekend......
Active participation in management meetings is essential to discuss the status of clients and strategize accordingly... requisitos del puesto completion of a master’s degree/mba or an equivalent qualification is required, coupled with practical work experience, preferably in hr tech, within roles such......
Únete a nuestro equipo century 21 abc home y comienza a disfrutar de nuestros beneficios durante tu carrera como asesor comercial en nuestra agencia... modernas instalaciones: disfruta de la comodidad de nuestra agencia, donde puedes trabajar y recibir a tus clientes cuando lo necesites......
¡únete a remote and talent como sales manager senior en chile! en remote and talent estamos ampliando nuestro equipo con un puesto de sales manager senior ubicado en chile... capacidad para trabajar en equipo y motivar a otros... residencia: latam (chile)... analizar datos de mercado y tendencias para......
¡únete a remote and talent como sales manager senior! en remote and talent, estamos ampliando nuestro equipo con un puesto de sales manager senior... capacidad para trabajar en equipo y motivar a otros... se valora: experiencia en startups... ofrecemos: salario estimado entre 200€ - 500€ mensuales......
Home support - visa patrocinada - asistente de enfermería - londres descripción de la empresareach_hr_consulting se especializa en la refruición de los profesionales de la salud de globalce... licencia de conducción localizaciónalrededores de londres, reino unido ofertas contribución permanente;salario......
Asistente de atención médica - visa patrocinada - home care - alojamiento pension plan - dorchester uk reach hr es una compañía que se especializa en reclutar profesionales de la salud... clases de inglés gratis semanalescapacitación que conduce a las calificaciones profesionales......
Home support / live in - patrocinador visa - reading uk reach_hr es una empresa especializada en la contratación de profesionales sanitarios... brindar primeros auxilios e inmovilización de la persona mayor en caso de accidente... requerimientos de aplicacion ciudadanía de la uebuen nivel de comunicación......