Clinical Trial Operations Manager

2 settimane fa

Italia Fortrea A tempo pieno
About the Role

We are seeking a highly skilled Clinical Trial Operations Manager to join our team at Fortrea. As a leading global contract research organization, we are dedicated to delivering high-quality clinical trials that transform the lives of patients worldwide.

In this role, you will be responsible for overseeing local operational clinical trial activities, ensuring compliance with regulatory and financial requirements, and driving country-specific trial commitments. Your expertise will play a crucial role in delivering clinical and financial contracts within fair market value, managing country budgets, and overseeing clinical research-related payments.

Key Responsibilities
  • Financial Management: Assist in the ownership of country and site budgets, ensuring timely and accurate financial reporting, and reconciling payments at study close-out.
  • Country Submissions & Local Language Materials: Execute and oversee clinical trial country submissions and approvals, develop local language materials, and work with IRB/IEC and Regulatory Authorities to ensure compliance.
  • Management & Quality Oversight: Manage country deliverables, timelines, and results, contributing to the development of local SOPs, and ensuring quality and compliance.
  • Collaboration: Work closely with internal and external stakeholders to ensure country deliverables are obtained, and collaborate with Regional Operations to align country timelines.
  • Local Process Oversight: Manage clinical and ancillary supplies, importing and exporting requirements, and ensure compliance with local regulations and laws.

Requirements

  • University/college degree (life science preferred) or certification in a related allied health profession.
  • Relevant clinical research experience in pharmaceutical or CRO industries or experience in a healthcare setting.
  • Thorough knowledge of ICH Guidelines and GCP, including a basic understanding of regulatory requirements in other countries.
  • Excellent communication and organizational skills, with the ability to work under pressure and manage multiple priorities.

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