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    Associate Clinical Data Manager

    Fortrea
    6-8 years
    Not Disclosed
    Bangalore
    10 Oct. 29, 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

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    Job Opportunity: Data Management Lead

    Company: Fortrea
    Location: [Insert Location]
    Job Type: [Insert Job Type]

    Company Overview

    As a leading global contract research organization (CRO), Fortrea is dedicated to scientific rigor and clinical development. We provide a diverse range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, we are transforming drug and device development for partners and patients around the world.

    Job Summary

    The Data Management Lead will oversee clinical data management (DM) activities, ensuring high-quality deliverables for multi-site studies involving healthy volunteers and patient populations. You will be accountable for all DM deliverables, managing resources effectively while meeting project timelines and client specifications.

    Key Responsibilities

    • Lead studies involving a combination of healthy volunteers and patient populations, ensuring efficient organization and prioritization of workload.
    • Be accountable for all assigned DM deliverables and provide guidance to the DM study team to maintain the highest quality standards.
    • Ensure all projects adhere to relevant protocols, global SOPs, and GCP standards.
    • Collaborate with Project Managers to develop timelines and communicate with interdisciplinary leads throughout the project lifecycle.
    • Provide leadership for DM project teams, facilitating internal meetings and coordinating with EDC Design, SAS Programming, and Statistics teams.
    • Monitor and manage project risks, proactively identifying mitigation strategies and communicating data-driven insights to achieve database lock dates.
    • Keep stakeholders informed about budget status, work scope changes, and timeline impacts.
    • Build and maintain client relationships, reviewing client satisfaction surveys to enhance service quality.
    • Track scope changes, ensuring proper approvals and documentation.
    • Mentor and coach internal study teams on DM processes and best practices.
    • Support DM managers in evaluating team performance and providing constructive feedback.
    • Stay updated on new DM technologies and industry trends for continuous process improvement.
    • Maintain accurate records of all work undertaken and perform reconciliation of clinical databases against safety and laboratory data.
    • Represent DM and overall Biometrics in new business opportunities and attend audits as necessary.
    • Promote Biometrics services to sponsors and perform other duties as assigned.

    Qualifications

    Education:

    • University/college degree, with equivalent experience considered in lieu of educational requirements.

    Experience:

    • 6 to 8 years of data management experience, including at least 1 year of direct sponsor management.
    • Experience in handling customer concerns and managing scope of work and budgets is preferred.
    • Strong knowledge of the clinical trial process, DM, clinical operations, and biometrics.
    • Excellent time management skills and ability to meet project timelines.
    • Strong organizational, communication, and interpersonal skills.
    • Ability to work collaboratively in a team environment.
    • Familiarity with medical terminology.

    Why Join Fortrea?

    Fortrea seeks motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Join our exceptional team and thrive in a collaborative environment that fosters 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 are committed to diversity and inclusion 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, family status, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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

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