Regulatory & Start Up Specialist 1 - Chile/home
hace 4 semanas
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.
**Qualifications**:
- Around 1 year of clinical research experience. Equivalent combination of education, training and experience.
- Intermediate/Advanced level of English
- Good communication and good interpersonal skills.
LI-NRJ #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
-
Study Start-up Specialist I/ii, Chile
hace 2 semanas
Santiago de Chile Novasyte A tiempo completoHelp 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...
-
Study Start-up Specialist I/ii, Chile
hace 2 semanas
Santiago de Chile Novasyte A tiempo completoHelp 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...
-
Associate Study Start-up Manager, Chile
hace 2 semanas
Santiago de Chile Novasyte A tiempo completoUnleash Your Potential It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward. Join IQVIA and see where...
-
Study Start Up Associate Ii
hace 4 semanas
Santiago de Chile ICON plc A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...
-
Study Start Up Associate Ii
hace 4 semanas
Santiago de Chile ICON A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...
-
Senior Study Start Up Associate
hace 4 semanas
Santiago de Chile ICON A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...
-
Senior Study Start Up Associate
hace 4 semanas
Santiago de Chile ICON plc A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...
-
Study Start-up Specialist I/ii, Chile
hace 2 semanas
Santiago, Metropolitana, Chile Novasyte A tiempo completoHelp create a healthier world: START RIGHT HERE AT IQVIA.Proficiency in English, both verbally and written are necessary.Please submit resume in English.Job OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs),...
-
Study Start Up Associate Ii
hace 2 semanas
Santiago de Chile ICON plc A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...
-
Senior Study Start Up Associate
hace 2 semanas
Santiago, Metropolitana, Chile ICON A tiempo completoAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives.ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing outsourced...
-
Senior Study Start Up Associate
hace 1 semana
Santiago de Chile ICON plc A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
-
Study Start Up Associate I/ii/sr
hace 3 semanas
Santiago de Chile Icon plc A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
-
Regulatory Affairs Specialist
hace 3 semanas
Santiago de Chile BAXTER A tiempo completo**This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...
-
Regulatory Control Systems Specialist
hace 2 meses
Santiago de Chile De Beers Group of Companies A tiempo completoCompany Description - Anglo American is a leading global mining company. Our products are the essential ingredients of almost every aspect of modern life. Our competitive portfolio of world-class operations and undeveloped resources provides the metals and minerals that make a cleaner, greener, and more sustainable world possible and meet the growing...
-
Site Activation Specialist en Chile
hace 2 semanas
Santiago de Chile Novasyte A tiempo completoThe Site Activation Specialists prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully...
-
Regulatory Affairs Specialist, Export Countries
hace 3 semanas
Santiago de Chile Solventum A tiempo completo**Job Description**: Regulatory Affairs Specialist, Export Countries (Solventum) - Chile or Colombia- 3M Health Care is now Solventum- At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations...
-
Site Activation Specialist en Chile
hace 2 meses
Santiago, Chile IQVIA A tiempo completoJob 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...
-
Site Activation Specialist en Chile
hace 4 semanas
Santiago, Chile IQVIA A tiempo completoJob 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...
-
Start-up Associate
hace 2 meses
Santiago de Chile Labcorp A tiempo completo¨ 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 guidelines ¨ Serve...
-
Start-up Associate
hace 2 semanas
Santiago, Metropolitana, Chile SAN Fortrea Chile Limitada A tiempo completoDescription ̈ 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...