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    Associate Clinical Data Manager(Fsp)-Remote

    Fortrea
    3-5 years
    Not Disclosed
    Remote, USA
    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

    About Fortrea

    As a leading global contract research organization (CRO) with a commitment to scientific excellence 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 over 20 therapeutic areas. Operating in more than 90 countries, Fortrea is dedicated to transforming drug and device development for partners and patients worldwide.

    Position Overview

    The Associate Clinical Data Manager plays a key role in assisting and leading the operations team alongside the Lead Data Manager (LDM). This includes developing project documentation, setting up systems, and establishing data validation procedures for junior staff. Additionally, this role involves supporting all data management activities, including database lock, while adhering to client quality expectations, project timelines, and budgets.

    Key Responsibilities

    • Collaborate closely with the Lead Data Manager on studies involving healthy and patient populations, multi-site operations, and medium-complexity protocol designs.
    • Act as a lead data reviewer and provide support to the LDM by performing data operational tasks, including data review and query management, ensuring quality standards are met.
    • Ensure all assigned projects comply with relevant protocols, Fortrea’s global SOPs, and specified GCP standards.
    • Assist the LDM in developing study milestone timelines, demonstrating the ability to interpret and follow timelines for timely deliverables. Suggest timeline adjustments based on study design as necessary.
    • Facilitate internal and external Data Management meetings.

    Work Environment

    • 100% remote

    Education & Qualifications

    • A university or college degree in life sciences, health sciences, information technology, or a related field is preferred.
    • Equivalent experience may be considered in lieu of a degree. Fluent in English, both written and verbal.

    Experience

    • 3 to 5 years of data management experience in Oncology is required.
    • Experience with Rave Lab Administration is required.
    • Preferred experience in managing customer concerns, Scope of Work, and budgets.
    • Solid understanding of clinical trial processes, data management, clinical operations, biometrics, and supporting system applications.
    • Strong time management skills with the ability to meet project productivity metrics and deadlines.
    • Ability to work collaboratively in a team environment, with excellent organizational, communication, and interpersonal skills.

    Compensation & Benefits

    • Pay Range: $85,000 - $100,000 (Note: This range does not include benefits, bonuses, commissions, or equity.)
    • Benefits: Comprehensive benefits are available for regular, full-time or part-time employees working 20 or more hours per week, including medical, dental, vision, life insurance, short-term/long-term disability, 401(K), Employee Stock Purchase Plan (ESPP), paid time off (PTO), or flexible time off (FTO), along with company bonuses where applicable.

    Join Us

    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. Join our exceptional team and thrive in 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

    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 made based on business needs and individual qualifications, without discrimination based on race, religion, color, national origin, gender, family status, sexual orientation, disability, or any other legally protected characteristic. We encourage all to apply.

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