Associate Manager, Clinical Trials Regulatory Management
3 semanas atrás
Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects.
RESPONSIBILITIES
Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers. Prepares and maintains core clinical trial submission dossiers in accordance with applicable regulatory requirements. Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, clinical trial justifications with minimum support of senior staff May strategically plan and perform European centralized submissions and facilitate global submissions May provide support on regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs) Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met. Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA). Deliver regulatory training/presentations as required. May perform additional tasks as deemed appropriate by Line ManagerREQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Good understanding of the regulations, directives and guidance supporting clinical Research and Development Demonstrates comprehensive regulatory/technical expertise Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach Strong ownership and oversight skills Demonstrated skills in chairing small meetings Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision Ability to establish and maintain effective working relationships with co-workers, managers and clients Strong software and computer skills, including MS Office applicationsMINIMUM REQUIRED EDUCATION AND EXPERIENCE
Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience* or high school diploma plus at least 9+ years’ experience* (*or combination of education, training and experience) EU-CTR knowledge & experience Global CTA submissions experiencePHYSICAL 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 Travel might be required
This role is not available for UK visa sponsorship
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
-
Lisbon, Portugal IQVIA Tempo inteiroPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...
-
Lisbon, Portugal IQVIA Tempo inteiroPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...
-
Lisbon, Portugal IQVIA Tempo inteiroPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions • Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents...
-
Sr Clinical Trial Assistant
2 semanas atrás
Lisbon, Portugal IQVIA Tempo inteiroClinical Trial Administrator, Single Sponsor dedicated Job Overview: CTA performs daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. By assisting in the coordination and administration of the study activities from the start up...
-
Clinical Research Associate
Há 1 mês
Lisbon, Portugal Novo Nordisk AS Tempo inteiroAre you an experienced Clinical Research Associate (CRA) looking for a new opportunity? Are you looking to advance your career in a dynamic and supportive environment? We have an exciting opportunity for you to join our team, based in either Lisbon or Porto! Join our team as a Clinical Research Associate and contribute to the development of life-changing...
-
Junior Clinical Research Associate
Há 1 mês
Lisbon, Portugal Novo Nordisk AS Tempo inteiroAre you passionate about clinical research? Do you already have some experience as a Clinical Research Associate, Study Coordinator or CTA? Do you want to build your career in one of the most leading companies in the worldwide pharmaceutical industry and contribute to our ongoing development in Portugal? We have an exciting opportunity for you to join our...
-
Clinical Research Associate
Há 1 mês
Lisbon, Portugal Novo Nordisk Tempo inteiroKey Responsibilities : • Conduct site selection, initiation, monitoring, and close-out visits. • Ensure compliance with study protocols, GCP (Good Clinical Practice), and regulatory requirements. • Monitor patient safety and data quality throughout the trial. • Collaborate with investigators and site staff to ensure smooth trial operations. •...
-
Clinical Research Associate
Há 1 mês
Lisbon, Portugal Novo Nordisk Tempo inteiroAre you an experienced Clinical Research Associate (CRA) looking for a new opportunity? Are you looking to advance your career in a dynamic and supportive environment? We have an exciting opportunity for you to join our team, based in either Lisbon or Porto!Join our team as a Clinical Research Associate and contribute to the development of life-changing...
-
Junior Clinical Research Associate
Há 1 mês
Lisbon, Portugal Novo Nordisk Tempo inteiroAre you passionate about clinical research? Do you already have some experience as a Clinical Research Associate, Study Coordinator or Clinical Trial Associate? Do you want to build your career in one of the most leading companies in the worldwide pharmaceutical industry and contribute to our ongoing development in Portugal? We have an exciting...
-
Clinical Supply Chain Manager
4 semanas atrás
Lisbon, Portugal IQVIA Tempo inteiroJob Overview The Clinical Supply Chain Manager is responsible for managing the strategic planning and execution of a program of assigned clinical supply chain projects. The Clinical Supply Chain Manager will support the ongoing development and optimization of the Clinical Trial Supplies department and processes. Essential Functions Interpret clinical...
-
Clinical Supply Chain Manager
3 semanas atrás
Lisbon, Portugal IQVIA Tempo inteiroJob Overview The Clinical Supply Chain Manager is responsible for managing the strategic planning and execution of a program of assigned clinical supply chain projects. The Clinical Supply Chain Manager will support the ongoing development and optimization of the Clinical Trial Supplies department and processes. Essential Functions Interpret clinical...
-
Clinical Trial Coordinator
Há 1 mês
Lisbon, Portugal Thermo Fisher Scientific Tempo inteiroAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...
-
Clinical Trial Coordinator
3 semanas atrás
Lisbon, Portugal Thermo Fisher Scientific Tempo inteiroAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...
-
Lisbon, Portugal Amgen Tempo inteiroHOW MIGHT YOU DEFY IMAGINATION? The Amgen Capability Center in Lisbon, Portugal (ACCP) will be home to over 300 multi-national and multi-cultural employees, representing a broad range of cross functional capabilities, including Commercial, General and Administrative, Research and Development and more. The ACCP will offer rich career growth and...
-
Junior Clinical Trial Administrator
3 semanas atrás
Lisbon, Portugal LIS Fortrea Development Ltd Sucursal em Portugal Tempo inteiroAs 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...
-
Junior Clinical Research Associate
Há 1 mês
Lisbon, Portugal Novo Nordisk Tempo inteiroKey Responsibilities : • Conduct site selection, initiation, monitoring, and close-out visits. • Ensure compliance with study protocols, GCP (Good Clinical Practice), and regulatory requirements. • Monitor patient safety and data quality throughout the trial. • Collaborate with investigators and site staff to ensure smooth trial operations. •...
-
Clinical Project Manager- 6 months contract- One sponsor
1 semana atrás
Lisbon, Portugal IQVIA Tempo inteiroJob Overview Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs,...
-
Senior Clinical Supply Chain Manager
4 semanas atrás
Lisbon, Portugal IQVIA Tempo inteiroJob Overview The Senior Manager, Clinical Supply Chain Management supervises, manages and provides oversight of Clinical Supply Chain Managers to ensure effective delivery of clinical supply chain projects (no line management) Essential Functions • Handles all aspects of their team’s performance and development including setting and reviewing of...
-
Senior Clinical Supply Chain Manager
3 semanas atrás
Lisbon, Portugal IQVIA Tempo inteiroJob Overview The Senior Manager, Clinical Supply Chain Management supervises, manages and provides oversight of Clinical Supply Chain Managers to ensure effective delivery of clinical supply chain projects (no line management) Essential Functions • Handles all aspects of their team’s performance and development including setting and reviewing of...
-
Clinical Research Associate
Há 1 mês
Lisbon, Portugal Thermo Fisher Scientific Tempo inteiroAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...
