Fsp - Sr. Regulatory & Start Up Specialist
hace 2 semanas
**Job Overview**
The **Regulatory & Start Up Specialist** will 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**
- Bachelor's Degree in life sciences.
- +3 years of clinical research experience within regulatory area in Argentina:
- Local submissions
- ICF customization
- Presentations to ethics committee & ANMAT.
- Fluent English: written and oral communication skills
- Ability to work independently
-
Regulatory & Start Up Specialist, Fsp
hace 5 meses
Buenos Aires, Argentina Novasyte A tiempo completoWe are looking for a Regulatory & Start Up Specialist to join our FSP team in a Home Based role! What You´ll Do 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...
-
Fsp - Regulatory and Start Up Specialist 2 - Arg
hace 5 meses
Buenos Aires, Argentina IQVIA A tiempo completo**Job Overview** The **Regulatory & Start Up Specialist 2** will 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...
-
FSP - Regulatory and Start Up Specialist 2 - ARG
hace 6 meses
Buenos Aires, Argentina IQVIA A tiempo completoJob Overview The Regulatory & Start Up Specialist 2 will 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. ...
-
Regulatory & Start Up Specialist, cFSP
hace 5 meses
Buenos Aires, Argentina IQVIA A tiempo completoWe are looking for a Regulatory & Start Up Specialist to join our cFSP team in a Home Based role! Location : Argentina & México What You´ll Do 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...
-
Reg & Start Up Spec 2
hace 6 meses
Buenos Aires, Argentina IQVIA A tiempo completoWe are looking for a **Regulatory & Start Up Specialist** to join our FSP team in a Home Based role! **What You´ll Do** 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...
-
Regulatory and Start Up Specialist
hace 1 mes
Buenos Aires, Argentina IQVIA A tiempo completoJob OverviewThe Regulatory and Start Up Specialist will 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...
-
Assoc Manager, Regulatory
hace 4 semanas
Buenos Aires, Argentina IQVIA A tiempo completo**Job Overview** Supervises a local work unit responsible for local regulatory activities. Sets day-to-day operational objectives for team, focusing on mentoring, coaching, and work flow coordination. **Essential Functions** - Manages staff's delivery of local regulatory activities in accordance with organization’s policies and applicable regulations....
-
Reg & Start Up Spec 2
hace 5 meses
Buenos Aires, Argentina Novasyte A tiempo completoWe are looking for a Regulatory & Start Up Specialist to join our FSP team in a Home Based role! What You´ll Do 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...
-
Reg & Start Up Specialist, Us Support, Cfsp
hace 6 días
Buenos Aires, Argentina IQVIA A tiempo completo**Regulatory & Start Up Specialist, cFSP - US Support** **Argentina - Full Home Based role** **Purpose**: 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...
-
Regulatory Specialist
hace 4 semanas
Buenos Aires, Argentina IQVIA A tiempo completo{"h1": "Regulatory & Start Up Specialist at IQVIA", "p": "We are seeking a highly skilled Regulatory & Start Up Specialist to join our cFSP team in a Home Based role. As a key member of our team, you will be responsible for performing tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or...
-
Regulatory Compliance Specialist
hace 2 semanas
Buenos Aires, Buenos Aires C.F., Argentina IQVIA A tiempo completoJob OverviewThe Regulatory Compliance Specialist will perform regulatory and start-up activities at a country level, ensuring adherence to local and international regulations, standard operating procedures, and project requirements. This role will also be responsible for maintaining internal systems, databases, and tracking tools.Key ResponsibilitiesUnder...
-
Senior Specialist, Country Study Start Up
hace 1 mes
Buenos Aires, Argentina AbbVie A tiempo completoJob SummaryWe are seeking a highly skilled and experienced Senior Specialist, Country Study Start Up to join our team at AbbVie. As a key member of our organization, you will be responsible for driving and executing all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries.Key...
-
Study Start Up Manager
hace 6 meses
Buenos Aires, Argentina Bristol Myers Squibb A tiempo completoEn Bristol Myers Squibb, nos inspira una sola visión: transformar la vida de los pacientes a través de la ciencia. En oncología, hematología, inmunología y enfermedades cardiovasculares, y una de las líneas de producción más diversas y prometedoras de la industria, cada uno de nuestros apasionados compañeros contribuye a innovaciones que impulsan...
-
Study Start Up Manager
hace 6 meses
Buenos Aires, Argentina Bristol Myers Squibb A tiempo completo**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Regulatory Affairs, Study Start Up Specialist
hace 6 meses
Buenos Aires, Argentina Mexico A tiempo completo**ALL CV´s MUST BE SUBMITTED IN ENGLISH IN ORDER TO BE CONSIDERED!** **Essential Functions**: - Assist/Advise project teams on all regulatory requirements for clinical studies - Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings - Review and adapt study specific...
-
Study Start Up Associate I
hace 2 meses
Buenos Aires, Argentina Icon plc A tiempo completoStudy Start Up Associate I (Regulatory Submissions) - Argentina - Hybrid Scheme ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it’s...
-
Country Start Up Specialist
hace 2 semanas
Buenos Aires, Argentina Medpace, Inc. A tiempo completoJob Summary: Join Medpace in CABA! As a Regulatory Submissions Coordinator you will have the opportunity to work within the Regulatory Submissions team, supporting our many projects and gaining vital experience in the study start up and site activation process of clincial trials. You will be a productive member of the team, and will be mentored and...
-
Regulatory Specialist
hace 4 semanas
Buenos Aires, Argentina IQVIA A tiempo completoJob OverviewThe Regulatory & Start Up Specialist will 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.Key...
-
Country Start Up Specialist
hace 5 meses
Buenos Aires, Argentina Medpace, Inc. A tiempo completoJob Summary: As a Regulatory Submissions Coordinator you will have the opportunity to work within Regulatory Submissions, supporting our many projects and gaining some vital experience. You will be a productive member of the team, and will be mentored and supported as you develop your skills. Working directly with Regulatory Submissions Coordinators, you...
-
Associate Study Start-up Manager, Argentina
hace 5 meses
Buenos Aires, Argentina 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...