Start-up & Regulatory Specialist II

Fortrea; Ciudad de México; Presencial; USD 60,000 - 90,000; Jornada completa

Descripción de la vacante

A leading company in global clinical trials seeks a dynamic leader for the start-up phase of impactful studies. This role emphasizes efficient processes, seamless initiation, and strict adherence to regulations, directly contributing to medical advancements. Ideal candidates should possess strong clinical research experience, leadership skills, and excellent organizational capabilities.

Formación

• Strong clinical research background (4+ years).
• In-depth knowledge of ICH-GCP and international regulations.
• Fluency in English and local language.

Responsabilidades

• Drive development and execution of start-up processes.
• Manage timelines, budgets, and documentation for trials.
• Ensure regulatory compliance and ethical standards.

Conocimientos

Clinical research background

Communication

Leadership

Organizational abilities

Teamwork

Descripción del empleo

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!

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