Clinical Trial Specialist
1 month ago
Maidenhead
Very competitive salary
Hybrid working 2x a week
Initial 12 month contract which is likely to be extended
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 pharmaceuticals.
Our client is looking for someone with 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 with company procedures.
• Populate relevant databases and activity trackers within agreed timelines, ensuring compliance with reporting requirements, and provide operational support for Regulatory and/or non-Regulatory systems critical for Regulatory submission and maintenance activities.
About You:
- 2 years of CTA experience, with a preference for involvement in global clinical trial submissions to regulatory agencies.
- ability to work effectively across diverse cultures and within complex matrix environments.
- in Information Technology, including MS Word, Excel, PowerPoint, Adobe Acrobat, and global databases.
- communication style, both written and verbal, with a solution-driven approach.
- high levels of initiative and independence, along with strong interpersonal skills and the ability to establish and maintain working relationships across remote geographical locations.
If you're interested in the above role then please click apply or get in touch to discuss further.
Consult will endeavour to contact candidates within 14 days of application. However, if you do not hear back after 2 weeks then please assume on this occasion, unfortunately, you have not been successful.
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