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    Associate Clinical Data Manager

    Fortrea
    8+ years
    Not Disclosed
    Bangalore Remote
    10 Nov. 21, 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 Description: Clinical Data Manager at Fortrea

    Fortrea, a leading global contract research organization (CRO), is looking for a motivated and experienced Clinical Data Manager to join our team. We specialize in delivering high-quality clinical development solutions to pharmaceutical, biotechnology, and medical device companies worldwide. With operations in over 90 countries, we aim to transform the drug and device development process and improve outcomes for partners and patients.

    Responsibilities/Duties:

    • Collaborate and report to the Lead Data Manager (LDM) for studies, including those with healthy and patient populations, multi-site operations, and moderate complexity in protocol design or client management requirements.
    • As the lead data reviewer, support the Lead Data Manager by performing data review, query management, and ensuring that internal and Sponsor quality standards are met.
    • Ensure all allocated projects comply with relevant protocols, Fortrea global SOPs, or client SOPs, and GCP standards.
    • Work with the LDM to establish study milestone timelines, ensuring timely deliverables while making suggestions for adjustments based on study design.
    • Assist or lead internal and external data management meetings.
    • Write, review, and approve trial data management documentation such as:
      • Study-specific case report forms
      • CRF Completion Guidelines
      • Data Management Plans
      • Data Quality Checks (edit checks)
    • Keep the LDM and internal teams updated on project and sponsor-related information, including scope changes and timeline impacts.
    • Ensure Data Transfer Agreements are established for all ancillary data vendors.
    • Track and manage scope changes with the Lead DM to obtain Sponsor approval and ensure scope adjustments are processed.
    • Support the training of new staff on data management processes specific to each project.
    • Perform quality checks on all aspects of data management operations to ensure data integrity and accuracy.
    • Coordinate with the Data Management study team to ensure timely delivery of data.
    • Oversee documentation and procedures upon project completion to ensure client satisfaction and quality data delivery.
    • Assist with internal or external audit processes and address client feedback in a timely manner.
    • Contribute to Database Lock and Unlock activities with the LDM.
    • Assist with administrative tasks related to Data Management and eTMF maintenance as needed.

    Education/Qualifications:

    • University/college degree in life sciences, health sciences, information technology, or related fields preferred.
    • Equivalent education and relevant work experience may be considered in lieu of a bachelor’s degree. Fluent in English, both written and verbal.

    Minimum Required Experience:

    • 8 to 10 years of Data Management experience.
    • Experience with customer concerns, managing scope of work, and budgets is preferred.
    • Strong knowledge of the clinical trial process, Data Management, clinical operations, biometrics, and supporting system applications.
    • Excellent time management skills with the ability to meet productivity metrics and timelines.
    • Strong organizational, communication, and interpersonal skills.
    • Team-oriented with good collaboration skills.
    • Familiarity with medical terminology and a scientific background is preferred.

    Why Join Fortrea? At Fortrea, we’re committed to transforming clinical trials, ensuring that life-changing therapies are delivered to patients faster. We’re looking for problem-solvers and creative thinkers to join our collaborative team. By joining Fortrea, you'll work in a supportive environment that fosters personal growth and offers opportunities for meaningful global impact.

    Fortrea is an Equal Opportunity Employer: We value diversity and inclusion in our workforce and do not tolerate any form of discrimination or harassment. We make employment decisions based on qualifications and business needs, regardless of race, religion, gender, sexual orientation, disability, or other legally protected characteristics. We encourage all qualified individuals to apply.

    For more information about Fortrea, visit www.fortrea.com.

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