Start-up & Regulatory Specialist II

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Full Remote
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Offer summary

Qualifications:

Strong clinical research background with 4+ years of experience in study start-up projects., In-depth knowledge of ICH-GCP guidelines and international regulations such as US FDA and MHRA., Excellent communication, leadership, and organizational skills are essential., Fluency in English and the local language is required..

Key responsabilities:

  • Drive the development and execution of efficient start-up processes for clinical trials.
  • Spearhead site-related start-up activities to ensure seamless initiation.
  • Collaborate with clients and internal teams, presenting at key meetings.
  • Manage timelines, budgets, and documentation with meticulous accuracy while ensuring 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

Industry :
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Communication
  • Leadership
  • Time Management
  • Teamwork
  • Organizational Skills

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