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    Senior Centralized Study Spec

    Fortrea
    2+ years
    Not Disclosed
    Bangalore
    10 Oct. 24, 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

    About Fortrea
    As a leading global contract research organization (CRO), Fortrea is dedicated to scientific rigor and has 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. With operations in over 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.

    Position Overview
    Title: Senior Centralized Study Specialist
    Location: Remote - USA

    In this role, you will play a crucial part in supporting clinical study management by overseeing various processes and ensuring compliance with departmental procedures. Your focus will be on maintaining quality and productivity while facilitating collaboration among study teams.

    Key Responsibilities

    • Standard Operating Procedures:

      • Follow all departmental SOPs and Work Instructions, ensuring compliance throughout all tasks.

    • Quality Assurance:

      • Complete daily tasks with an emphasis on quality and productivity.
      • Track and report metrics as required by management within specified timelines.

    • Monitoring and Reporting:

      • Execute high-quality monitoring and reporting plans, including specialized requests for approved protocols.
      • Identify and implement process improvements proactively.

    • Mentoring:

      • Provide mentorship and training to junior team members.

    • Clinical Systems Management:

      • Manage clinical systems and study documents, supporting eTMF management.
      • Maintain study databases (CTMS, IWRS, EDC) and assist study teams in resolving data management queries.

    • Communication and Coordination:

      • Manage internal and external communications effectively.
      • Support study payments (site and vendor) and review the study performance dashboard.

    • Documentation and Compliance:

      • Maintain Trial Master File documentation and participate in TMF quality checks.
      • Actively support compliance metrics for TMF, CTMS, and overall project health.

    • Project Leadership:

      • Lead centralized study support resources on projects, facilitating communication and task delegation.
      • Update timelines and milestones within project scheduling tools and escalate risks as needed.

    • Risk Management:

      • Update the Xcellerate Risk Identification & Issue Resolution (XRIM) tool and ensure resolution of outstanding action items.

    • Facilitation:

      • Organize and document meetings, ensuring effective collaboration among study teams.
      • Oversee vendor management and ensure successful partnerships with support groups.

    Why Join Fortrea?

    Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling 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 the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to protected characteristics. We encourage all qualified individuals to apply.

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

    Visit Fortrea's website for more details.

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