Clinical Trials Manager
1 week ago
Regeneron Pharmaceuticals, Inc is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European Medicines Agency (EMA) via the Clinical Trial Information System (CTIS).
Key Responsibilities:- Collaborate with Regulatory Affairs and Clinical Trial Management to plan Clinical Trial Applications (CTA) and determine key study achievements and country allocation strategies.
- Ensure trials align with national regulatory requirements, strategize submissions for timely approvals, and archive all trial-related documents in compliance with regulations and company policies.
- Identify and capture key study achievements, participating countries, institutions, and primary investigators in the CTIS database, and manage this information throughout the study lifecycle.
- Implement risk management strategies to mitigate potential issues impacting Part II activities and prioritize any questions or requests for information related to clinical trial applications.
- Oversee vendors involved in collecting and maintaining CTA information, and coordinate with local ethics committees for approvals and addressing concerns.
- Supervise and report on the progress of Part II activities, ensuring alignment with trial timelines and objectives, and stay updated on regulatory changes and industry standard methodologies to improve processes.
- Bachelor's degree in a related field with at least five years of functional experience in Pharma/Biotech/CRO industry, 7+ years of relevant experience, and a minimum of 1-3 years of clinical submission experience.
- Strong interpersonal, collaboration, and stakeholder management skills, along with good written and verbal communication abilities.
- Innate ability to prioritize and run multiple projects simultaneously.
This role requires a subject matter authority in Clinical Trial Application (CTA) in EU countries, partnering with EU countries on their local site strategy allocation. If you have an innate understanding of the clinical drug development process, ICH/GCP, and regulatory guidelines/directives, and possess strong interpersonal and collaboration skills, we encourage you to apply.
-
Clinical Trials Manager
2 weeks ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full timeClinical Investigations ManagerRegeneron Pharmaceuticals, Inc is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Trials team, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European...
-
Clinical Trials Manager
2 weeks ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full timeClinical Investigations ManagerRegeneron Pharmaceuticals, Inc is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Trials team, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European...
-
Clinical Trials Manager
3 days ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full timeThe Clinical Trials Manager will be responsible for planning and delivering EU Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European Medicines Agency (EMA) via the Clinical Trial Information System (CTIS). This role requires coordination with Regulatory Affairs, Clinical Trial Management, and Clinical...
-
Clinical Trials Manager
1 week ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full timeClinical Investigations ManagerRegeneron Pharmaceuticals, Inc is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Trials group, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European...
-
Clinical Trials Manager
1 week ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full timeClinical Investigations ManagerRegeneron Pharmaceuticals, Inc is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Trials group, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European...
-
Clinical Trials Manager
3 days ago
Uxbridge, United Kingdom Regeneron Full timeJob Summary:The Clinical Trials Manager will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European Medicines Agency (EMA) via the Clinical Trial Information System (CTIS). This role requires strong collaboration with Regulatory Affairs, Clinical...
-
Clinical Trials Manager
2 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob Title: Clinical Investigations ManagerRegeneron is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European...
-
Clinical Trials Manager
2 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob Title: Clinical Investigations ManagerRegeneron is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European...
-
Clinical Trials Manager
3 weeks ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full timeClinical Investigations ManagerRegeneron Pharmaceuticals, Inc is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Trials team, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European...
-
Clinical Trials Manager
3 weeks ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full timeClinical Investigations ManagerRegeneron Pharmaceuticals, Inc is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Trials team, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European...
-
Clinical Trials Manager
2 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob Title: Clinical Investigations ManagerRegeneron is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European...
-
Clinical Trials Manager
2 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob Title: Clinical Investigations ManagerRegeneron is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European...
-
Clinical Trials Manager
5 days ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full timeJob Title: Clinical Investigations ManagerRegeneron Pharmaceuticals, Inc is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements...
-
Clinical Trials Manager
1 week ago
Uxbridge, United Kingdom Regeneron Full timeJob Title: Clinical Investigations ManagerRegeneron is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European...
-
Clinical Trials Manager
1 week ago
Uxbridge, United Kingdom Regeneron Full timeJob Title: Clinical Investigations ManagerRegeneron is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European...
-
Clinical Trials Manager
5 days ago
Uxbridge, United Kingdom Regeneron Full timeJob Title: Clinical Investigations ManagerRegeneron is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European...
-
Clinical Trials Manager
4 weeks ago
Uxbridge, United Kingdom US TECH SOLUTIONS LIMITED Full timeUnlock Your Potential as a Clinical Trials Manager US TECH SOLUTIONS LIMITED is seeking a highly skilled Clinical Trials Manager to join our team in the UK. As a key member of our Clinical Operations department, you will play a crucial role in the execution of Phase I - IV clinical trials across various therapeutic areas. Your Key...
-
Clinical Trials Manager
4 weeks ago
Uxbridge, United Kingdom US TECH SOLUTIONS LIMITED Full timeUnlock Your Potential as a Clinical Trials Manager US TECH SOLUTIONS LIMITED is seeking a highly skilled Clinical Trials Manager to join our team in the UK. As a key member of our Clinical Operations department, you will play a crucial role in the execution of Phase I - IV clinical trials across various therapeutic areas. Your Key...
-
Clinical Trials Manager
2 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob Title: Clinical Investigations ManagerRegeneron is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European...
-
Clinical Trials Manager
2 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob Title: Clinical Investigations ManagerRegeneron is seeking a highly skilled Clinical Investigations Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for planning and delivering European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European...
