REGULATORY & START UP SPECIALIST I - CENTRAL HUB
Descripción de la oferta de empleo
This role may also involve maintenance activities.
Essential Functions.
Serve as Single Point of Contact (SPOC) for assigned studies, liaising with investigative sites, Site Activation Managers (SAMs), Project Management teams, and other departments.
Ensure adherence to SOPs, Work Instructions (WIs), quality standards, and project timelines.
Conduct start-up and site activation activities in line with applicable regulations, SOPs, and work instructions.
Distribute completed documents to sites and internal project team members.
Prepare and review site regulatory documents for completeness and accuracy.
Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
Review and provide feedback to management on site performance metrics.
Review, establish, and agree on project planning and timelines.
Implement monitoring measures and contingency plans as needed.
Inform team members about the completion of regulatory and contractual documents for individual sites.
Review, track, and follow up on the progress, approval, and execution of documents, including regulatory, ethics, Informed Consent Forms (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
Provide local expertise to SAMs and project teams during initial and ongoing project timeline planning.
Perform quality control of documents provided by sites.
May have direct contact with sponsors on specific initiatives.
Qualifications.
Degree in Life Sciences.
At least 2 years of clinical research experience, with at least 1 year in Regulatory & Start-Up.
Advanced level of English.
#LI-Remote IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Learn more at https://jobs.
qvia.
om
Detalles de la oferta
- MSC Quintiles Mexico S. de R.L. de C.V.
- Sin especificar
- 29/11/2024
- 27/02/2025
Praat escuela de vuelo sc requiere personal técnico aeronáutico para su base ubicada en aeropuerto intercontinental de querétaro técnicos en mantenimiento clase i técnicos en mantenimiento clase il, electrónica/laministería favor de enviar cv indicando que se cuenta con certificados, examen médico y......
Raise up those around you... progress updates: wrap up your day with a quick loom video update to keep the team informed and aligned on project progress... strong communication skills: excellent written english and competent spoken english are required to effectively collaborate with our international......
I am thrinadh, i work as a technical lead recruiter for cliecon solutions inc... net) strong experience in customization and configuration strong knowledge data migration and power platform integration good experience with security and role-based access control ms dynamics 365 – f&o; – finance functional......
We are a consulting company & workday specialist that enhances the integration of technology into companies through a professional team and a unique way of doing business based on understanding and closeness... we are a consulting company & workday specialist, which enhances the integration of technology......
Requisitos del puestorequirements communicates with customers in english only reports to customer success manager; promptly and accurately respond to our customer’s inquiries regardless of channel submitted provide timely follow up to customer downloads and support requests escalates customer inquiries......
This is an exciting opportunity lead in the development of the clients operations in central and south america... wasterecruit are working with a global trader of plastic scrap and recyclates to recruit a trader in central america... candidates who know and understand the logistics and regulations of......
Great command of the english language ability to handle objections, utilize persuasive skills - easy with small talks ability to thrive in fast pace virtual platform profound work ethics willingness to learn and grow onboarding process: audition interview hardware checkup script training role-play......
Experiencia: en equipos de medición, tablas de muestreo, manejo de sap, interpretación de i... inspector de calidad parque industrial nexxus adn/cienega de flores escolaridad: preparatoria terminada o carrera técnica horarios rotativos de 8 horas de día, tarde y noche... 51 suelo semanal: $3,384......
Sección i y ii, nave i, mza... buscamos un ejecutivo de ventas con experiencia en la industria de metales ferrosos y no ferrosos para nuestra planta... prestaciones de ley (imss, infonavit, aguinaldo, vacaciones, prima vacacional) bono por cumplimiento de objetivos servicio de comedor servicio de cafetería......
Revisarás y atenderás correos electrónicos, y actualizarás nuestra herramienta de click up para mantener todo en orden... experiencia con herramientas de gestión de proyectos como click up y comprensión básica de herramientas de seguridad y redes... oportunidades de desarrollo profesional y crecimiento......
