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Local Study Manager - FSP Team - Home Based Italy

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Fortrea

Oct 30

  • Job
    Full-time
    Mid Level
  • Research & Development
    Healthcare
  • Milan
  • Quick Apply

AI generated summary

  • You need a life science degree or 4+ years in clinical research; knowledge of ICH, GCP, drug development, and fluency in local and English required.
  • You will ensure compliance and performance of protocols, oversee CRAs, manage budgets, collaborate with vendors and stakeholders, and provide clinical trial education to sites.

Requirements

  • 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.
  • In lieu of the above requirement, candidates with minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
  • Thorough understanding of the drug development process.
  • Fluent in local office language and in English, both written and verbal.

Responsibilities

  • Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
  • POC for assigned protocols. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated).
  • Responsible for quality and compliance in assigned protocols in country. Oversees CRAs and CTCs on assigned projects. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed. Oversees associate CRMs assigned to the Client and work on training needs in collaboration with functional vendor.
  • Responsible for collaboration with functional outsourcing vendors, investigators, other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols. Responsible for clinical trial education to sites. Country POC for programmatically outsourced trials for assigned protocols.
  • Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations.
  • All other duties as needed or assigned.

FAQs

What is the role of a Local Study Manager at Fortrea?

The Local Study Manager is accountable for execution and oversight of local operational clinical trial activities, with responsibilities for regulatory compliance, managing budgets, and maintaining relationships with investigators and external partners.

Is this position remote?

Yes, this position is home-based in Italy.

What qualifications are required for this role?

A university/college degree in a life science field is preferred, or certification in a related allied health profession. Alternatively, candidates with a minimum of four years of relevant clinical research experience may be considered.

What does “FSP Team” stand for in the job title?

FSP stands for Functional Service Provider, which refers to a model where services are outsourced for specific functions within clinical research.

What are the main responsibilities of the Local Study Manager?

Responsibilities include ensuring compliance with ICH/GCP and country regulations, managing local trial activities, quality oversight, collaboration with external partners, and internal strategic alignment.

Is prior experience in clinical research necessary for this role?

Yes, a thorough knowledge of ICH Guidelines, GCP, and the drug development process, along with relevant clinical research experience, is necessary.

How does the Local Study Manager interact with external parties?

The Local Study Manager is responsible for collaboration with functional outsourcing vendors, investigators, and other external partners, ensuring effective communication and education related to clinical trials.

Will there be opportunities for professional growth in this role?

Yes, Fortrea fosters a collaborative workspace that nurtures personal growth and offers opportunities for making a meaningful impact in clinical research.

What languages are required for this position?

Fluency in the local office language and English, both written and verbal, is required.

Does Fortrea promote diversity in the workplace?

Yes, Fortrea is committed to diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.

Science & Healthcare
Industry
10,001+
Employees
2023
Founded Year

Mission & Purpose

We are creative thinkers with decades of clinical trial experience who drive innovative solutions powered by insights from data and technology. As we tackle challenges in today’s world, we know that we need to be nimble and agile. That’s why we work side-by-side with our partners to eliminate inefficiencies from the process so we can help them deliver life-changing therapies faster for patients, caregivers and healthcare providers worldwide.