Study Start-up Specialist I/ii, Chile

hace 2 semanas

Santiago de Chile Novasyte A tiempo completo

Help create a healthier world: START RIGHT HERE AT IQVIA.

Proficiency in English, both verbally and written are necessary.

Please submit resume in English.

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions
- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
- Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing 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 project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.

KNOWLEDGE, SKILLS & ABILITIES:
- Knowledge of clinical research process related to study start-up and medical terminology- A basic understanding of Regulatory and Central/Local ethic submission processes for assigned countries- Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members- Excellent organizational and interpersonal skills- Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities- Ability to manage multiple competing priorities within various clinical trials- Working knowledge of current ICH GCP guidelines and applicable regulations- Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor administrative staff- Excellent verbal and written communication skills required in local language for assigned countries- Ability to work independently, prioritize and work with a matrix team environment is essential- Working knowledge of Word and Excel is required- Ability to travel periodically if needed

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

MINIMUM RECRUITMENT STANDARDS:
- Bachelor’s degree (or equivalent), preferably in science or related field and 6 months - 4 years relevant experience. Specialist I needs at least 6 months experience and Specialist II needs at least 1.5 years experience related to study start-up and maintenance activities.- Equivalent combination of education, training and experience

LI-RW1

LI-Remote

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

  • Start-Up Associate

    hace 2 días

    Santiago, Chile Fortrea A tiempo completo

    Description ¨ Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance¨ Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and...

  • Start-up Associate

    hace 3 días

    Santiago de Chile Fortrea A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Start-up Associate

    hace 3 días

    Santiago, Chile Fortrea A tiempo completo

    Description ¨ Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance ¨ Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and...

  • 8510 product Specialist Ii

    hace 2 semanas

    Santiago, Chile Santander A tiempo completo

    i Ad Product Specialist Welcome This site asks for consent to use your data · perm_identity · perm_identity Personalised advertising and content, advertising and content measurement, audience research and services development · devices devices Store and/or access information on a device · Data p ... i Ad Production Specialist Role Purpose ·...

  • 8509 product Specialist I

    hace 2 semanas

    Santiago, Chile Santander A tiempo completo

    i Ad Specialist I AmerisourceBergen · What you will be doing · - ONSITE AT CLIENT HEALTH SYSTEM · -PRIMARY DUTIES AND RESPONSIBILITIES:_ · 1. Demonstrates theability to fully and accurately utilize IndiCare and all itsfunctionality for successful claims management. 2. Identifiesand qualifies pa ... i Ad Product Specialist Welcome This site asks...

  • Pfl mat 8467 financial Control Specialist I

    hace 6 días

    Santiago de Chile Santander A tiempo completo

    PFL_MAT_8467_Financial Control Specialist I Country: Chile **WHAT YOU WILL BE DOING** HACER EL ANÁLISIS E INTERPRETAR RESULTADOS Y PLANES DE ACCIÓN PARA LAS DIFERENTES ÁREAS DE NEGOCIO DE LA DIVISIÓN DE GLOBAL CORPORATE BANKING DEL BANCO, CON EL FIN DE PROVEER INFORMACIÓN PARA LA TOMA DE DECISIONES ESTRATÉGICAS DE LA ALTA DIRECCIÓN ALINEAD

  • Mine Engineering Study Lead

    hace 6 días

    Santiago, Chile Glencore A tiempo completo

    **Job highlights**- Be Part of a Growing Team - Santiago,Santiago Province, Chile - Work with leaders in yourfield **Job ID**- (Recruiter)2202**Closing date**-15/08/2023**Last Updated**- 17/07/2023***- We are one of theworld’s largest producers and marketers of copper with our miningoperations and development projects in key mining regions of...

  • Mine Engineering Study Lead

    hace 1 semana

    Santiago, Chile Glencore A tiempo completo

    **Job highlights**- Be Part of a Growing Team - Santiago,Santiago Province, Chile - Work with leaders in yourfield **Job ID**- (Recruiter)2202**Closing date**-15/08/2023**Last Updated**- 17/07/2023***- We are one of theworld’s largest producers and marketers of copper with our miningoperations and development projects in key mining regions of...

  • Sr Clin Res Assoc I

    hace 6 días

    Santiago de Chile Labcorp A tiempo completo

    The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Covance, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assures the implementation of project plans, as assigned. Function as leader for projects of limited scope, as assigned. Assume line...

  • Study Manager-metals

    hace 7 días

    Santiago de Chile Hatch A tiempo completo

    **Requisition ID**:85365 **Job Category**:Metals **Location**:Santiago, Santiago Province, Chile Join a company that is passionately committed to the pursuit of a better world through positive change. With more than 65 years of business and technical expertise in mining, energy, and infrastructure, our 10,000 colleagues in 150 countries tirelessly work...

  • Cra I

    hace 2 días

    Santiago de Chile Labcorp A tiempo completo

    Labcorp Drug Development is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. Are you ready for the next step in your career? We are currently recruiting for a Clinical Research Associate I in Chile. Role description: - Ensure the study staff who will conduct the protocol have...

  • BI Specialist

    hace 2 semanas

    Chile Brass Chile A tiempo completo

    Introduzca el título del trabajo o la habilidad para buscar Trabajos relevantes Introduzca su ciudad o código postal para mostrar los trabajos en su ubicación En Teamwork nosencontramos en búsqueda del mejor BI Specialist para nuestrocliente Adidas. Te invitamos a ser parte de la principal empresaligada al mundo deportivo que se apasiona y conecta...

  • Hse Advisor, Specialist

    hace 2 semanas

    Santiago, Chile Ausenco A tiempo completo

    Health, Safety & Environment Specialist · Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. · At ABB, we have the clear goal of driving diversity and inclusion acros ... i Ad i Ad **The Elevator Pitch: Why will you enjoy this new...

  • Sales Specialist

    hace 1 semana

    Santiago, Chile Mindwork A tiempo completo

    Las Condes, Chile Mindwork A tiempo completo Hey ¿Eres una persona apasionada por las ventas y la prospección de clientes? Tenemos la oportunidad perfecta para ti **Sales Specialist en Start-up de Tecnología** Si quieres ser parte del emocionante mundo de las start-ups y trabajar en ventas directas y prospección de nuevos clientes, esta es tu gran...

  • Local Study Associate Director

    hace 2 semanas

    Santiago, Chile Astrazeneca A tiempo completo

    Inicio Trabajos para Local Study Associate Director e... 1 Trabajos para Local study associate director en la Chile Local Study Associate Director ermanen AstraZeneca Company 03.10.2023 • Tiene la responsabilidad general de los compromisos de estudio dentro del país y de la entrega oportuna de datos con la calidad requerida. • Dirige el equipo de...

  • Site Contract Specialist I

    hace 3 días

    Santiago de Chile Thermo Fisher Scientific A tiempo completo

    Performs and coordinates all activities required to finalize site contracts (including, contractual terms and conditions, associated investigator grant budget(s) payment schedule terms and conditions, ancillary and site-specific documents), with investigator sites, pharmacies, laboratories or other relevant contractual parties during the lifecycle of the...

  • Cra I

    hace 2 semanas

    Santiago de Chile Labcorp A tiempo completo

    Site monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned. Essential Job Duties: 1) Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical...

  • Cra I

    hace 1 día

    Santiago de Chile Fortrea A tiempo completo

    Site monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned. Essential Job Duties: 1) Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical...

  • TAX Specialist

    hace 2 semanas

    Chile Brass Chile A tiempo completo

    Introduzca el título del trabajo o la habilidad para buscar Trabajos relevantes Introduzca su ciudad o código postal para mostrar los trabajos en su ubicación • Verificar laimputación de gastos, ingresos y costos de acuerdo al plan de cuentascontables de la organización • Establecer las actualizacionessegún normativa IFRS • Revisar la...

  • CRA1 - Santiago de Chile

    hace 2 semanas

    Santiago, Chile IQVIA A tiempo completo

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in...