Hybrid working 2x a week
Scope:
This is an excellent opportunity for an experienced CTS Coordinator to join a global pharmaceutical company for an initial 12 months with the potential for this to be extended. This role has come about due to expansion and an increase in the production of pharmaceutical. They are looking for someone with at around 2 years of CTS. This is a supportive role looking at completion of company databases and submissions tracking and would suit someone who is looking to get experience of the pharmaceutical industry, particularly regulatory affairs within clinical trials.
Responsibilities:
• Oversee a portfolio of CTAs, managing the preparation and dissemination of documentation for new initial CTAs and all CTA maintenance activities, including substantial amendments and end-of-trial notifications.
• Offer guidance on submission strategy, country-specific requirements, and operational assistance for Regulatory submission preparation and processing of amendments.
• Ensure adherence to approved company CTA processes within established timelines.
• Demonstrate a thorough understanding of the Clinical Trial Regulation (CTR) process and its requirements.
• Track key project milestones, compare actual progress with planned activities and timelines, and communicate any issues or changes to relevant stakeholders and management in accordance...