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    Senior Centralized Study Asso

    Fortrea
    2+ years
    Not Disclosed
    Bangalore
    10 Oct. 16, 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

    Rewritten Job Description

    As a leading global contract research organization (CRO) with a commitment to scientific rigor and decades of clinical development experience, Fortrea offers pharmaceutical, biotechnology, and medical device clients a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in over 90 countries, Fortrea is dedicated to transforming drug and device development for partners and patients worldwide.

    Key Responsibilities:

    • Adhere to all relevant departmental Standard Operating Procedures (SOPs) and Work Instructions.
    • Execute daily tasks to ensure quality and productivity.
    • Track and report metrics as directed by management within established timelines.
    • Participate in opportunities for process improvement and assist with the implementation of updated processes and procedures.
    • Additional duties may include:
      • Managing clinical systems and access management.
      • Overseeing study documents and supporting electronic Trial Master File (eTMF) management.
      • Maintaining study databases (CTMS, IWRS, EDC, etc.).
      • Supporting the study team in data review and related activities.
      • Tracking and following up with Clinical Research Associates (CRAs) on outstanding issues.
      • Assisting in generating study-specific reports.
      • Managing internal and external communications.
      • Ensuring compliance with training requirements for study teams.
      • Overseeing study payments for sites and vendors.
    • Document and track study activities using relevant forms and tools, as well as applicable Project Management Systems with guidance.
    • Maintain Trial Master File documentation within the designated TMF platform; participate in TMF quality checks and track/archive documents as needed.
    • Actively support compliance metrics related to TMF, CTMS, and overall project health.
    • Update timelines and milestones in project scheduling tools, CTMS, and project governance tools, escalating risks to timelines as necessary.
    • Update the Xcellerate Risk Identification & Issue Resolution (XRIM) tool and follow up on outstanding action items, including protocol deviations.
    • Assist Functional Leads in drafting project plans and coordinating feedback and execution between the study team and client.
    • Collaborate with the Study Team to maintain "WISER moments."
    • May support additional cross-functional tasks based on project needs.

    Additional Responsibilities:

    • Facilitate communication and collaboration within the study team by organizing and attending team meetings as needed.
    • Document and distribute meeting notes for internal and external calls in accordance with study requirements.
    • Oversee vendor management.

    Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. We are committed to revolutionizing 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. For more information about Fortrea, visit www.fortrea.com.

    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 made based on the needs of our business and the qualifications of the individual, without discrimination based on race, religion, color, national origin, gender (including pregnancy or other medical conditions), family or parental status, marital status, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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