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    Clinical Data Manager

    Excelya
    5+ years
    Not Disclosed
    Remote, USA
    10 Dec. 12, 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

    We offer a personal and authentic experience within a young, ambitious health company, striving to become the clinical research leader in Europe, powered by our 800 Excelyates. Our unique one-stop provider service model – combining full-service, functional service provision, and consulting – empowers our Excelyates to grow through a diverse range of projects. In collaboration with leading experts, Excelya advances scientific, managerial, and human knowledge to improve the patient journey.

    For our team members, excelling with care means benefiting from a dynamic professional environment that encourages personal, intellectual, and operational participation. Together, we aim to be the best in our field, empowering each Excelyate to express their natural talents, develop their full potential, and invest their unique selves in our unique project.

    What we offer:

    Job Description:

    • Oversee the implementation, monitoring, and adherence to deadlines for various Data Management activities from study set-up to database freeze.
    • Define and implement quality, security, and compliance standards to ensure data integrity and availability in line with expectations and usage contexts.
    • Supervise and organize Data Management activities conducted by CROs, ensuring timely and efficient completion.
    • Coordinate interactions between CROs and project teams regarding Data Management tasks.
    • Contribute to, review, and approve key study documents such as the Data Management Plan (DMP), Data Validation Plan (DVP), Data Review Plan (DRP), and External Data Transfer Specifications.
    • Coordinate the design and updates of the Case Report Form (CRF), and ensure the implementation of eCRF, including annotated CRF and specifications, database verification, input screens, and consistency tests.
    • Review and approve various study-related documents, including synopses, protocols, and study reports.
    • Conduct quality control on data, reviews biometrics deliverables such as listings, and supports data review, coding, and reconciliation.
    • Supervise data collection and contribute to the validation, review, and reconciliation of study data.
    • Ensure that activities leading to database freeze are tracked, documented, and performed in compliance with quality standards.
    • Maintain the eTMF (electronic Trial Master File).
    • Represent Data Management in all project meetings, ensuring alignment and effective communication.
    • Ensure all Data Management activities are compliant with ethical standards, ICH/GCP guidelines, and regulatory requirements.
    • Provide expertise in data management to optimize project management.
    • Contribute to CRO selection processes and the updating of quality documents and standards within the scope of data management activities.

    Minimum Requirements:

    • 10 years of experience in clinical data management, with a minimum of 5 years in eDC using systems like Medidata Rave, TrialMaster, Ennov, or Veeva Vault.
    • Extensive experience in all aspects of Data Management processes (UAT, data cleansing, control definition, data review, data transfer management, and reconciliations).
    • Previous experience as a Data Manager in pharmaceutical laboratories, biotech companies, or CROs.
    • Proven ability to supervise CROs on data management activities for clinical studies.
    • Strong knowledge of CDISC standards, including CDASH and SDTM.
    • Proficient with coding dictionaries such as MedDRA, WHODrug.
    • Experience in eCRF design and SAS programming is a plus.
    • Knowledge of good practice regulatory guidelines (GCDMP, ICH).
    • Fluent in written and spoken English.

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