Associate Manager, Clinical Trials Regulatory Management
4 weken geleden
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
-
Clinical Trial Assistant
2 dagen geleden
Amsterdam, Nederland IQVIA VoltijdPlease note this role is based in Breda IQVIA is a leading global provider of contract research services, advanced analytics and technology solutions to the life sciences industry formed through the merger of IMS Health and Quintiles. Take your therapeutic expertise to the next level and help drive the evolution of clinical development for a variety of...
-
Amsterdam, Nederland IQVIA VoltijdPrepares 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...
-
Amsterdam, Nederland IQVIA VoltijdPrepares 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 Trial Assistant
1 week geleden
Amsterdam, Nederland ICON VoltijdICON 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. The Clinical Trials Associate is responsible for assisting clinical study teams in the execution...
-
Clinical Trial Assistant
1 week geleden
Amsterdam, Noord-Holland, Nederland ICON VoltijdICON 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.The Clinical Trials Associate is responsible for assisting clinical study teams in the execution of...
-
Clinical Research Associate
4 weken geleden
Amsterdam, Nederland Amaris Consulting VoltijdJob description Amaris Consulting is a leading global pharmaceutical and clinical research organization dedicated to advancing healthcare through innovative research and development. Our team is composed of passionate professionals committed to improving patient outcomes and advancing medical science. Position Overview:...
-
Clinical Research Associate
4 weken geleden
Amsterdam, Nederland Amaris Consulting VoltijdJob description Amaris Consulting is a leading global pharmaceutical and clinical research organization dedicated to advancing healthcare through innovative research and development. Our team is composed of passionate professionals committed to improving patient outcomes and advancing medical science. Position Overview:...
-
Clinical Trial Manager The Netherlands
4 weken geleden
Amsterdam, Nederland Pharmiweb VoltijdDescription For one of our FSP clients we are currently recruiting for a Clinical Trial Manager. This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, Sponsor policies and procedures, quality standards and adverse event reporting...
-
Clinical Trial Manager The Netherlands
2 weken geleden
Amsterdam, Noord-Holland, Nederland Pharmiweb VoltijdFor one of our FSP clients we are currently recruiting for a Clinical Trial Manager. This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, Sponsor policies and procedures, quality standards and adverse event reporting requirements...
-
Clinical Research Associate II
1 week geleden
Amsterdam, Noord-Holland, Nederland Allucent VoltijdAt AllucentTM, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Clinical Research Associate II (CRA II) to join our A-team (hybrid*/remote). As a CRA II at Allucent, you will independently...
-
Clinical Supply Chain Manager
4 weken geleden
Amsterdam, Nederland IQVIA VoltijdJob 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
4 weken geleden
Amsterdam, Nederland IQVIA VoltijdJob 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 Project Manager
3 weken geleden
Amsterdam, Nederland AtriCure VoltijdClinical Project Manager Amsterdam, Netherlands Req #2109 Thursday, June 6, 2024 As a leading provider of innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions, electrophysiologists and cardiothoracic surgeons around the globe count on AtriCure to deliver best-in-class solutions that can treat even the most...
-
Clinical Research Associate II
2 weken geleden
Amsterdam, Noord-Holland, Nederland Allucent VoltijdAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Clinical Research Associate II (CRA II) to join our A-team (hybrid*/remote). As a CRA II at Allucent, you will independently...
-
Manager, Clinical Program Quality
4 weken geleden
Amsterdam, Nederland IAVI Voltijd**Job Title**: Manager, Clinical Program Quality **Location**: Amsterdam, Netherlands; Cape Town, South Africa; South Africa Remote; Nairobi, Kenya; OR United Kingdom Remote **Reports to**: Director, Clinical Program Quality **Position Summary**: Are you an experienced clinical quality and compliance leader who is eager to make an impact in a mission-driven...
-
Principal Clinical Trial Manager
4 weken geleden
Amsterdam, Nederland Pharmiweb VoltijdDescription Principal Clinical Trial Manager - Oncology or Ophtlamology experience required Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical...
-
Sr. Clinical Research Associate
4 weken geleden
Amsterdam, Nederland Allucent VoltijdAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Sr. Clinical Research Associate (Sr. CRA) to join our A-team (hybrid*/remote). As a Sr. CRA at Allucent, you will independently...
-
Clinical Research Associate II
1 week geleden
Amsterdam, Nederland Allucent VoltijdAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Clinical Research Associate II (CRA II) to join our A-team (hybrid*/remote). As a CRA II at Allucent, you will independently...
-
Clinical Research Associate II
1 maand geleden
Amsterdam, Nederland Allucent VoltijdAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Clinical Research Associate II (CRA II) to join our A-team (hybrid*/remote). As a CRA II at Allucent, you will independently...
-
Sr. Clinical Research Associate
4 weken geleden
Amsterdam, Nederland Allucent VoltijdAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Sr. Clinical Research Associate (Sr. CRA) to join our A-team (hybrid*/remote). As a Sr. CRA at Allucent, you will...
