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    Local Study Manager - Fspx Team - Home Based Madrid

    Fortrea
    0-1 years
    Preferred by Comapny
    Spain
    11 Nov. 24, 2024
    Job Description
    Job Type: Full Time 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

    Job Title: Local Study Manager
    Location: Madrid, Spain
    Time Type: Full-Time

    About Fortrea

    Fortrea is a global leader in contract research organizations (CRO), offering comprehensive clinical development, patient access, and technology solutions across over 20 therapeutic areas. With operations in more than 90 countries, Fortrea is dedicated to transforming drug and device development for our partners and patients worldwide.

    This position is for future opportunities at Fortrea, where you will play an essential role in the successful execution of clinical trials.

    Position Overview

    The Local Study Manager is responsible for overseeing and executing local clinical trial activities. This position ensures that clinical trials are conducted in compliance with regulatory standards, quality standards, and client policies. The role requires a deep understanding of the local regulatory environment and clinical trial management while fostering strong relationships with clients, vendors, and external partners. As a key customer-facing role, the Local Study Manager will have a significant impact on client relationships and successful trial delivery.

    Key Responsibilities

    • Performance & Compliance (30%):

      • Ensure that trials are conducted in compliance with ICH/GCP, country regulations, and client policies.
      • Manage the performance of protocols and oversee adverse event reporting.
      • Act as the point of contact for assigned protocols.

    • Management (20%):

      • Proactively track and manage deliverables, timelines, and results to meet country commitments.
      • Forecast resource needs and manage local business requirements, including contracts and budgets.

    • Quality Oversight (20%):

      • Oversee quality and compliance for assigned protocols in-country.
      • Manage and train Clinical Research Associates (CRAs) and Clinical Trial Coordinators (CTCs) involved in the trial.
      • Conduct quality control visits and address performance issues.

    • External Customer Facing (20%):

      • Collaborate with functional outsourcing vendors, investigators, and other external partners.
      • Oversee site selection, recruitment, and clinical trial education at sites.
      • Act as the point of contact for programmatically outsourced trials.

    • Internal Collaboration & Strategy (10%):

      • Collaborate with local and regional teams to align on key decisions.
      • Support strategy development consistent with long-term corporate needs.

    Qualifications

    • Education:

      • University/college degree in life sciences (preferred) or certification in an allied health profession (e.g., nursing, medical technology).
      • Alternatively, candidates with at least two years of relevant clinical research experience in pharmaceutical or CRO industries or healthcare settings will be considered.

    • Experience:

      • Strong understanding of ICH guidelines, GCP, and regulatory requirements.
      • Knowledge of the drug development process.
      • At least two years of experience in clinical research, with a focus on study management.

    • Skills:

      • Fluent in the local language and English (written and verbal).
      • Excellent communication, leadership, and organizational skills.
      • Ability to manage multiple protocols and priorities simultaneously.

    Why Fortrea?

    At Fortrea, we are passionate about overcoming barriers in clinical trials. Join us in a collaborative, dynamic environment where your contributions will have a meaningful global impact. You will have the opportunity to grow professionally while contributing to the swift delivery of life-changing therapies to patients in need.

    Fortrea is an Equal Opportunity Employer
    Fortrea is committed to diversity and inclusion and encourages individuals from all backgrounds to apply. We do not discriminate based on any legally protected characteristic.

    For more information about how we collect and store your personal data, please see our Privacy Statement.

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