Senior Clinical Trial Operations Specialist

3 giorni fa

Roma, Lazio, Italia Fortrea A tempo pieno

Company Overview

Fortrea is a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.

Our company conducts operations in over 90 countries and transforms drug and device development for partners and patients across the globe. As a part of our team, you will be responsible for executing and overseeing local operational clinical trial activities and having ownership, oversight, and impact on local regulatory and financial compliance at a country operations level.

Estimated Salary Range: $80,000 - $110,000 per year

Job Description

The successful candidate will be accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight, and impact on local regulatory and financial compliance, at a country operations level at the client. This role has a significant impact on how a country can deliver country-specific trial commitments and objectives, especially during study start-up. The ability to indirectly influence investigators, vendors, external partners, and country managers to deliver these commitments is a must.

This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country-based regulations, laws, and procedures with minimal support from the client management. The ideal candidate should have skilled knowledge of budget and contract negotiations, the local ethics, legislation, and regulatory environment, submission and approval processes, development of local Informed Consent as well as other site-ready and ongoing study deliverables.

Moreover, the candidate will be able to proactively develop risk management and mitigation plans in the country and resolve issues locally. They will also work closely with internal and external stakeholders to ensure seamless execution of clinical trials and meet business objectives.

Required Skills and Qualifications

  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
  • Four-six years of clinical research experience
  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
  • Fluent in local office language and in English, both written and verbal

Benefits

As a valued member of our team, you will enjoy a comprehensive benefits package, including competitive salary, generous paid time off, and opportunities for professional growth and development.

Others

If you are a motivated problem-solver and creative thinker who shares our passion for overcoming barriers in clinical trials, we encourage you to apply for this exciting opportunity. Join our exceptional team and embark on a rewarding career journey with Fortrea, where personal growth is nurtured, and your contributions make a meaningful global impact.

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