REGULATORY & START UP SPECIALIST I, US SUPPORT, CFSP
Descripción de la oferta de empleo
The RSU Specialist 1 proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country.
US.
Responsibilities Primary responsibilities include but are not limited to.
Ensuring successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope primarily central IRB/EC sites Establishing the country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/Regulatory Affairs Proactively identifying and communicating issues impacting delivery and providing proposed solutions Attending regional/area start up calls and providing input for assigned sites/studies Collection of essential documents from sites and completing quality check (ALCOA) Compiling and submitting ethics and other required local submissions including customization of ICFs, patient facing materials and safety reporting Coordinating with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements Qualifications.
Bachelor's Degree required, degree in health care or scientific field preferred A minimum of 1-2 years of clinical research experience and +1 year of study start up management experience supporting US.
Advanced English level Good analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives Good interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment 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
- IQVIA
- Sin especificar
- 11/11/2024
- 09/02/2025
I am thrinadh, i work as a technical lead recruiter for cliecon solutions inc... act as the l2/l3 (level-2/level-3) support to solve the customer issue collaborate with cross-group peers both proactively and reactively... please check review the below requirement and reply me back with your updated resume......
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... generous time off: enjoy 21 days of paid vacation plus 12 public holidays, with the flexibility to choose between us dates or your local country's......
We want to make sure you have what you need for a long, productive, and fulfilling career with us... we love when your pets visit us at the office! :) global perspective & people-centric approach great and dynamic work atmosphere... we are a consulting company & workday specialist that enhances the......
Description the newrich network is hiring a customer service agent to handle incoming support tickets for our digital platforms... requisitos del puestorequirements communicates with customers in english only reports to customer success manager; promptly and accurately respond to our customer’s inquiries......
We want to make sure you have what you need for a long, productive, and fulfilling career with us... we love when your pets visit us at the office! :) global perspective & people-centric approach great and dynamic work atmosphere... support workday operations by suggesting monitoring and recommending......
This includes assisting customers in the design, implementation, scoping, estimations, support phases and other engagements... we want to make sure you have what you need for a long, productive, and fulfilling career with us... we love when your pets visit us at the office! :) global perspective &......
Market: us and ca... 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......
· provide training and support to end-users and administrators as needed... · perform platform upgrades, troubleshoot issues, and provide ongoing support to ensure the smooth functioning of servicenow instances... requisitos del puestoeducation (required and/or preferred): · bachelor’s degree (ba/bs)......
Responsibilities support the entire application lifecycle (concept, design, test, release, and support)... we work hard & have fun: - our remote culture allows us to work harder, remain accountable, and maximize work-life balance... in order to do so, our team members must believe in our mission, and......
