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    Senior Clinical Data Manager(Fsp)Remote

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

    Job Title: Senior Clinical Data Manager (Remote)

    Company Overview: Fortrea is a leading global contract research organization (CRO) dedicated to scientific rigor and clinical development excellence. With operations in over 90 countries, we provide pharmaceutical, biotechnology, and medical device clients with a wide array of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Our mission is to transform drug and device development for partners and patients worldwide.

    Position Overview: The Senior Clinical Data Manager will lead studies involving diverse populations, including healthy volunteers and patients, as well as multi-site and complex protocol designs. This role requires strong client management skills and the ability to prioritize workload effectively. As the Study Manager, you will be accountable for all data management (DM) deliverables, providing guidance to your DM study team and reviewing outputs to ensure the highest quality.

    Key Responsibilities:

    • Ensure all allocated projects adhere strictly to relevant protocols, global SOPs, and GCP standards.
    • Collaborate with Project Managers or FSP Leads to establish timelines that meet contracted milestones, facilitating communication with various team leads and participating in study initiation meetings.
    • Provide leadership and accountability for the DM project team; lead internal project meetings focused on data, coordinate with EDC Design, SAS Programming, Statistics, and PK teams to ensure deliverables are well-planned and executed.
    • Proactively identify potential risks and mitigation strategies, communicating data-driven insights to achieve database lock dates.
    • Maintain awareness of functional group deliverables to support risk management and consult with Project Managers or functional group management as needed.
    • Keep relevant teams informed of project or sponsor-related information, including budget status, work scope changes, and timeline impacts.
    • Coordinate the receipt and inventory of data-related information from clinical sites and vendors to meet deliverable timelines.
    • Ensure all necessary documentation and procedures are completed upon project completion.

    Remote Work: This position is 100% remote.

    Education and Qualifications:

    • A university/college degree in life sciences, health sciences, information technology, or a related field is preferred.
    • Equivalent experience may be considered in lieu of a bachelor’s degree.

    Experience:

    • A minimum of 8 years of combined early or late-stage DM experience, with at least 2 years in direct sponsor management and 2 years in technical mentoring.
    • Proven experience in customer negotiations and managing Scope of Work and budgets.
    • Strong knowledge of the clinical trial process, DM, clinical operations, biometrics, and relevant system applications.
    • Ability to lead project strategies and achieve departmental goals while encouraging team members to seek solutions.
    • Understanding of the CRO industry’s relationship and regulatory obligations with pharmaceutical and biotechnological companies.
    • Excellent time management skills and ability to adhere to project productivity metrics and timelines.

    Benefits: Fortrea offers a comprehensive benefits package for regular, full-time or part-time employees working 20 or more hours per week. This includes medical, dental, vision, life insurance, STD/LTD, 401(K), ESPP, paid time off (PTO) or flexible time off (FTO), and company bonuses where applicable.

    Join Us: Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our commitment to overcoming barriers in clinical trials. Join our exceptional team and thrive in a collaborative environment that fosters personal growth and allows 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 value 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 regard to race, religion, color, national origin, gender, family status, marital status, sexual orientation, gender identity, disability, or any other legally protected characteristic. We encourage all qualified candidates to apply.

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

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