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Local Study Manager - Fsp Team - Home Based Italy

2+ years
Not Disclosed
10 Oct. 30, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Overview

As a leading global contract research organization (CRO), Fortrea is passionate about scientific rigor and boasts 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. Operating in over 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.

Job Description

This role is for upcoming future opportunities at Fortrea. The Local Study Manager is accountable for the execution and oversight of local operational clinical trial activities. This position has ownership of local regulatory and financial compliance at a country operations level, ensuring adherence to ICH GCP and country regulations. The Local Study Manager plays a crucial role in delivering country-specific trial commitments and objectives, particularly during the study phase.

As a customer-facing role, the Local Study Manager will build business relationships and represent Fortrea with investigators, functional outsourcing partners, and other external stakeholders. This position requires the ability to make independent decisions and oversee important activities relevant to clinical research in accordance with predetermined global policies and commitments, with the support of the Country Research Director or Therapeutic Director.

Key Responsibilities

  • Performance: Accountable for performance and compliance for assigned protocols in accordance with ICH/GCP and country regulations, as well as client policies and quality standards. (30%)

  • Management: Serve as the point of contact for assigned protocols, proactively driving execution and performance to meet country commitments. Collaborate closely with local CO roles and forecast resource needs. (20%)

  • Quality Oversight: Ensure quality and compliance in assigned protocols. Oversee CRAs and CTCs, ensuring training compliance and conducting quality control visits. Review monitoring reports and escalate issues as needed. (20%)

  • External Customer Facing: Collaborate with functional outsourcing vendors, investigators, and external partners. Oversee site validations, selection, and recruitment, providing education about clinical trials. (20%)

  • Internal Collaboration & Strategy: Work with local Pharmacovigilance, Regulatory Affairs, and Global Medical Affairs to support strategy development consistent with corporate needs. (10%)

  • Additional Duties: Perform all other duties as assigned.

Qualifications

  • University/college degree in a life science field preferred, or certification in a related health profession (nursing, medical, laboratory technology).
  • Minimum of four (4) years of relevant clinical research experience in pharmaceutical or CRO industries, or equivalent experience in a healthcare setting may be considered.
  • Thorough knowledge of ICH Guidelines and GCP, with an understanding of regulatory requirements in various countries.
  • Strong understanding of the drug development process.
  • Fluent in the local office language and in English, both written and verbal.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment is to revolutionize the development process, ensuring the swift delivery of life-changing therapies to patients in need. Join our exceptional team and thrive in a collaborative environment that nurtures personal growth and enables you to make a meaningful global impact.

Equal Opportunity Employer

Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in our workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications without regard to race, religion, color, national origin, gender, sexual orientation, gender identity, age, veteran status, disability, or any other legally protected characteristic.

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