Clinical Trials Operations Manager

4 settimane fa


Italia Fortrea A tempo pieno
Overview
Fortrea, a leading global contract research organization (CRO), seeks a highly skilled Clinical Trials Operations Manager to oversee local clinical trial activities and ensure regulatory compliance in various countries. As a key member of our team, you will be responsible for executing country-specific trial commitments, managing budgets, and collaborating with internal and external stakeholders.

About Fortrea
We are a forward-thinking company dedicated to transforming drug and device development through scientific rigor and expertise. Our team is passionate about overcoming barriers in clinical trials and delivering life-changing therapies to patients worldwide.

Job Description
This role involves managing country deliverables, timelines, and results for assigned protocols. Key responsibilities include:
  • Executing and overseeing local clinical trial country submissions and approvals.
  • Developing and maintaining local language materials, including informed consents and translations.
  • Collaborating with IRB/IEC and Regulatory Authorities on submission and approval-related interactions.
  • Managing country budgets, tracking payments, and ensuring financial compliance.
  • Providing oversight and support to local vendors as needed.

Required Skills and Qualifications
To succeed in this role, you must have:
  • A university degree in a life science or a related field, or equivalent experience.
  • At least 4-6 years of clinical research experience in the pharmaceutical or CRO industries or a healthcare setting.
  • Thorough knowledge of ICH Guidelines and GCP, as well as local regulatory requirements.
  • Excellent communication and organizational skills, with the ability to work under pressure and meet deadlines.
  • Familiarity with investigator start-up documents and operational project teams.

Benefits
We offer a competitive salary and benefits package, including a base salary of $90,000 per year, plus bonuses and benefits that reflect your performance and contributions to our team. Additionally, we provide opportunities for professional growth and development, allowing you to advance your career and achieve your goals.

Estimated Salary: $90,000 - $120,000 per year

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