Start-up & Regulatory Specialist II

Work set-up: 
Full Remote
Contract: 
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

Minimum of 4 years of clinical research experience, particularly in study start-up projects., Strong knowledge of ICH-GCP guidelines and international regulations such as US FDA and MHRA., Excellent communication, leadership, and organizational skills., Fluency in English and the local language, with the ability to manage multiple priorities in a virtual environment..

Key responsibilities:

  • Lead and develop efficient start-up processes for clinical trials.
  • Manage site-related start-up activities to ensure seamless initiation.
  • Collaborate with clients and internal teams, including presenting at key meetings.
  • Oversee timelines, budgets, and documentation to ensure regulatory compliance.

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Fortrea XLarge https://fortrea.com/
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Job description

Shape the Future of Global Clinical Trials

Join our dynamic team and lead the crucial start-up phase of impactful clinical trials, with opportunities for international exposure. You'll ensure projects are delivered on time, within budget, and to the highest quality standards, directly contributing to life-changing medical advancements.

Your Impact:

· Drive the development and execution of efficient start-up processes.

· Spearhead site-related start-up activities, ensuring seamless initiation.

· Collaborate with clients and internal teams, presenting at key meetings.

· Manage timelines, budgets, and documentation with meticulous accuracy.

· Ensure regulatory compliance and adherence to the highest ethical standards.

Your Expertise:

· Strong clinical research background (4+ years), including proven previous experience with study start-up projects.

· In-depth knowledge of ICH-GCP guidelines and international regulations (US FDA, MHRA).

· Excellent communication, leadership, and organizational abilities.

· Proven ability to manage multiple priorities and inspire teamwork in a virtual environment.

· Fluency in English and the local language.

Ready to make a difference? Apply now!

Learn more about our EEO & Accommodations request here.

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Organizational Skills
  • Teamwork
  • Communication
  • Leadership

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