Clinical Trials Manager

1 week ago


Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full time
Clinical Investigations Manager

Regeneron 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 Medicines Agency (EMA) via the Clinical Trial Information System (CTIS).

Key Responsibilities:
  • Collaborate with Regulatory Affairs, Clinical Trial Management, and Clinical Transparency teams to ensure seamless coordination and execution of clinical trials.
  • Develop and implement strategies for timely approvals and compliance with national regulatory requirements.
  • Manage and maintain accurate records of trial-related documents and information in the CTIS database.
  • Identify and mitigate potential risks impacting Part II activities and prioritize requests for information related to clinical trial applications.
  • Supervise vendors involved in collecting and maintaining CTA information and coordinate with local ethics committees for approvals and addressing concerns.
  • Monitor and report on the progress of Part II activities, ensuring alignment with trial timelines and objectives.
Requirements:
  • Strong understanding of the clinical drug development process, ICH/GCP, and regulatory guidelines/directives.
  • Excellent interpersonal, collaboration, and stakeholder management skills, with good written and verbal communication abilities.
  • 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.
  • Innate ability to prioritize and run multiple projects simultaneously.


  • Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    Clinical 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...


  • Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    Clinical 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...


  • Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    The 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...


  • Uxbridge, United Kingdom Regeneron Full time

    Job 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...


  • Uxbridge, United Kingdom Regeneron Full time

    Job 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...


  • Uxbridge, United Kingdom Regeneron Full time

    Job 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...


  • Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    Clinical 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...


  • Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    Clinical 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...


  • Uxbridge, United Kingdom Regeneron Full time

    Job 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...


  • Uxbridge, United Kingdom Regeneron Full time

    Job 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...


  • Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    Job 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...


  • Uxbridge, United Kingdom Regeneron Full time

    Job 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...


  • Uxbridge, United Kingdom Regeneron Full time

    Job 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...


  • Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    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 outlined by the...


  • Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    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 outlined by the...


  • Uxbridge, United Kingdom Regeneron Full time

    Job 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...


  • Uxbridge, United Kingdom US TECH SOLUTIONS LIMITED Full time

    Unlock 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...


  • Uxbridge, United Kingdom US TECH SOLUTIONS LIMITED Full time

    Unlock 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...


  • Uxbridge, United Kingdom Regeneron Full time

    Job 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...


  • Uxbridge, United Kingdom Regeneron Full time

    Job 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...