Associate Manager, Clinical Trials Regulatory Management
2 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...
-
Clinical Research Associate
1 dia atrás
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 10 horas
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...
-
Lead Clinical Research Associate
Há 4 dias
Lisbon, Portugal Novo Nordisk Tempo inteiroThe position Accountable for the independent country management clinical trial, for all its stages, to a high quality in accordance with the Company’s policies and procedures, compliance with the clinical study protocol and local and global regulations and guidelines whilst maintaining the standards of the Novo Nordisk Way. Ensures the achievement of...
-
Clinical Research Associate
1 dia atrás
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 10 horas
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
1 dia atrás
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 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...
-
Junior Clinical Research Associate
1 dia atrás
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. •...
-
Manager, Clinical Data Management
3 semanas atrás
Lisbon, Portugal IQVIA Tempo inteiroJob Responsibilities Provide line and functional management of Data Management technical experts, with a team size of around 15-20 people. Manage and prioritize resource assignments, as well as workload management across Technical Design and SAS Programming teams ensuring project milestones are met according to agreed timelines with high quality. ...
-
Lisbon, Portugal IQVIA Tempo inteiroJoin us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, Technology, analytics and...
-
Senior Clinical Research Associate
Há 1 mês
Lisbon, Portugal IQVIA Tempo inteiroSenior Clinical Research Associate IQVIA is the Human Data Science Company oriented to drive human health outcomes forward. When you join IQVIA Portugal as a sponsor-dedicated CRA, you’ll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers. With access to...
-
Experienced Clinical Research Associate
Há 3 dias
Lisbon, Portugal IQVIA Tempo inteiroIQVIA is the Human Data Science Company oriented to drive human health outcomes forward. When you join IQVIA Portugal as a sponsor-dedicated CRA, you’ll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers. With access to world-class training and mentoring,...
-
Lisbon, Portugal IQVIA Tempo inteiroIQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, Technology, analytics and human ingenuity to drive healthcare...
-
Associate Client Services Lead
Há 1 mês
Lisbon, Portugal IQVIA Tempo inteiroJob Description The Associate Client Services Lead , under the supervision of senior members of Client Services team, serves as the main point of contact for their respective region's portfolio studies, manages the client / IQVIA PL relationship (as appropriate), oversee payment management projects and ensure sponsor satisfaction is achieved. Manage...
-
Lisbon, Portugal SGS Tempo inteiroJob Description We are looking for an experienced Regulatory Compliance product manager to join SGS DIGICOMPLY in Chiasso and lead our clients onboardings, Regulatory and food safety project implementations and renewals. This role is fundamental in ensuring that customers are getting the most out of the SGS Digicomply platform. You'll play a key role to...
-
Sr Site Enablement Solutions Project Lead
3 semanas atrás
Lisbon, Portugal IQVIA Tempo inteiroRole Overview: The Site Enablement Solutions team at IQVIA provides qualified, clinically experienced research staff to clinical trial sites globally to accelerate and optimize the performance of clinical trials. By supplying sites with support for data entry, patient recruitment, patient visits, assessments, and other tasks, IQVIA is able to relieve the...
-
Lisbon, Portugal Fortrea 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...
-
Lisbon, Portugal Taleo Consulting Tempo inteiroMission. Our banking client is on the lookout for an experienced Regulatory Business Analyst to join our dynamic team. This role will play a crucial part in the implementation of the Digital Operational Resilience Act (DORA) , covering all six pillars of the program. What will you do? Act as a Business Analyst supporting the 6 pillars within...
-
Regulatory Affairs Manager
Há 1 mês
Lisbon, Portugal IQVIA Tempo inteiroThe Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register several of development projects into the international region. This role is key to driving both the Regulatory strategy and execution.• Provide...
-
Lisbon, Portugal IQVIA Tempo inteiroJob Overview This position is responsible for providing line management to an assigned data management team. This role is also responsible for delivering strategic solutions and process improvements for clients. Essential Functions Providing leadership of clinical data management activities across one or more programs enabling planning,...