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    Central Monitoring Manager

    Fortrea
    10+ years
    Not Disclosed
    Bangalore
    10 Sept. 26, 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

    About Fortrea

    As a leading global contract research organization (CRO), Fortrea is dedicated to scientific rigor and boasts decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff operating in more than 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.

    Position Overview

    We are looking for an experienced professional to perform central monitoring activities for multiple studies, ensuring accurate tracking and reporting. You will manage a portfolio of studies for a customer, acting as their primary point of contact.

    Key Responsibilities

    • Oversee central monitoring for multiple studies, ensuring timely and accurate tracking and status reporting.
    • Manage the customer relationship, collaborating on proposal development and cost reviews.
    • Support the development of sponsor presentations and bid defense materials.
    • Analyze and interpret data to proactively manage risks at the study and site levels.
    • Lead central monitoring activities, including site, subject, and study level reviews, and mentor less experienced team members.
    • Assist the PMO in preparing initial Risk Management Registers and coordinate site risk assessments.
    • Ensure appropriate critical data and process definitions are implemented in EDC design.
    • Develop and establish risk factor mitigation strategies and monitor intervention levels.
    • Conduct ongoing dashboard reviews and recommend mitigation actions based on findings.
    • Evaluate and approve changes to monitoring levels, ensuring compliance with plans and sponsor needs.
    • Oversee project quality and risk reports to ensure client satisfaction.
    • Coach project teams to enhance central monitoring capabilities.
    • Contribute to process development and improvements using Six Sigma and LEAN methodologies.
    • Perform any additional duties assigned by management.

    Qualifications

    • University or college degree from an accredited institution; relevant experience may be considered in lieu of educational requirements.
    • Minimum of 10+ years of relevant clinical research experience in a pharmaceutical company, CRO, or equivalent, with increasing responsibility in roles such as project management, clinical monitoring, and data management.

    Why Join Us?

    Fortrea is seeking motivated problem-solvers and creative thinkers who are passionate about overcoming barriers in clinical trials. We are committed to revolutionizing the development process to ensure the swift delivery of life-changing therapies to patients. Join our exceptional team and experience a collaborative workspace that nurtures personal growth, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

    Equal Opportunity Employer Statement

    Fortrea is proud to be an Equal Opportunity Employer. As an EOE/AA employer, we are dedicated to 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 race, religion, color, national origin, gender (including pregnancy or other medical conditions), family 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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