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Local Study Manager - FSPx Team - Home Based Madrid

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Fortrea

1mo ago

  • Job
    Full-time
    Junior Level
  • Research & Development
    Healthcare
  • Madrid
  • Quick Apply

AI generated summary

  • You need a degree in life sciences or relevant experience in clinical research. Knowledge of ICH/GCP, drug development, and fluency in English and local language are essential.
  • You will ensure protocol performance, manage timelines and resources, oversee quality and compliance, collaborate with external partners, and support internal strategy alignment.

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.
  • MANDATORY, In lieu of the above requirement, candidates with minimum of two or more years of relevant clinical research experience as local study manager 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

  • PERFORMANCE: 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. 30%
  • MANAGEMENT: 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). 20%
  • QUALITY OVERSIGHT: 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. 20%
  • EXTERNAL CUSTOMER FACING: 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. 20%
  • INTERNAL COLLABORATION & STRATEGY: 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. 10%
  • 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 the execution and oversight of local operational clinical trial activities, ensuring compliance with ICH GCP and country regulations while managing relationships with investigators and external partners.

What qualifications are required for this position?

A university/college degree in a life science field or certification in a related health profession is preferred. Candidates with a minimum of two years of relevant clinical research experience as a local study manager in the pharmaceutical or CRO industries may also be considered.

Is experience in a healthcare setting acceptable for this role?

Yes, experience in a healthcare setting can be considered as relevant experience in lieu of formal educational requirements.

What skills are critical for success in this position?

Critical skills include a strong understanding of clinical trial planning, management, quality standards, and the ability to build and maintain professional relationships with investigators and external stakeholders.

Will I need to collaborate with external partners in this role?

Yes, the role involves collaboration with functional outsourcing vendors, investigators, and other external partners to ensure successful execution of clinical trials.

Is fluency in languages required for this position?

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

What kind of impact does this role have on clinical trials?

This role significantly impacts how a country can deliver specific trial commitments and objectives, ensuring compliance with local regulations and quality standards.

What geographic location is this position based in?

This position is home-based in Madrid, Spain.

Is there an opportunity for professional growth within Fortrea?

Yes, Fortrea encourages personal growth and collaboration, providing opportunities to make a meaningful global impact.

Is Fortrea an equal opportunity employer?

Yes, Fortrea is proud to be an Equal Opportunity Employer and promotes diversity and inclusion in the workforce.

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Fortrea

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.