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    Sr Clinical Data Specialist

    Fortrea
    4-6 years
    Not Disclosed
    Bangalore
    10 Aug. 8, 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

    Fortrea: Transforming Drug and Device Development

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide 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.

    Key Responsibilities

    • Data Review: Examine clinical trial data in accordance with Global Data Management Plans and standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.
    • Ancillary Programs: Run diagnostics, special listings, and reconciliation discrepancy listings to support clinical trial data review.
    • Query Management: Generate, resolve, and track queries to address data issues identified during data review activities.
    • Aggregate Review: Perform comprehensive review of clinical data by patient, site, and project to identify data trends (patient safety, compliance, etc.) and inconsistencies that require further investigation.
    • Quality Control: Apply quality control procedures and checks to ensure data quality standards (client and Fortrea) are met.
    • Document Review: Potentially review project documents such as protocols, CRFs (or eCRF Completion guidelines, Data Management Plans).
    • Plan Development: Assist in developing Global Data Management Plans and Quality Management Plans to deliver accurate, timely, consistent, and quality clinical data.
    • Database Design: Assist in reviewing database design and annotating the CRF (eCRF) according to specifications.
    • Data Review Guidelines: Create and assist in developing data review guidelines, ensuring consistency with the clinical data model and CRF/eCRF completion/monitoring conventions.
    • System Testing: Assist in the development and testing of data management system edit/data validation checks and special listings/procedures for data review and discrepancy management.
    • Timeline Management: Work with Lead Data Manager or Lead Data Reviewer to build timelines and meet contracted milestones by communicating with leads in different disciplines and the full project team.
    • Budget Management: Ensure service and quality meet agreed-upon specifications per the DMP and scope of work in the budget. Inform Lead Data Reviewer of budget overages and assist in the Change Order Log process, if applicable.
    • Quality Control on Activities: Perform quality control on data management activities, including study documentation, query generation, and integration, to ensure internal and client quality standards are achieved.
    • Audit Support: Support and address client or internal audits as appropriate, resolving all issues within a suitable timeframe. Address client comments with the study team.
    • Mentoring and Coaching: Mentor and coach project staff on project-specific, global, standardized data management processes.
    • Additional Duties: Perform other related duties as assigned by management.

    Qualifications

    Education

    • University/college degree in life sciences, health sciences, information technology, or related subjects preferred.
    • Experience and/or education plus relevant work experience, equating to a bachelor's degree, will be accepted in lieu of a bachelor’s degree.

    Experience

    • 4 to 6 years of Clinical Data Management experience.
    • Some knowledge of the clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
    • Time management skills and the ability to adhere to project productivity metrics and timelines.

    Join Fortrea

    Fortrea seeks motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, 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. As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without discrimination based on race, religion, color, national origin, gender (including pregnancy or medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, 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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