Senior Clinical Data Manager

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🕒 Março 18

🏈 Alabama – Remoto

🏈 Alabama – Remote

⏰ Tempo Integral

🟠 Sênior

📊 Cientista de Dados

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CRS

SiteLinkedInTodas as Vagas

11 - 50 funcionários

A Civil Recovery Solutions Limited (CRS) oferece a próxima geração em serviços especializados de recuperação civil e litígios civis. A CRS combina uma equipe de profissionais altamente experientes com novas tecnologias poderosas e ferramentas sob medida para gerenciar o processo de recuperação civil de maneira extremamente eficaz e eficiente. O modelo da CRS, de fácil integração, é radicalmente diferente e flexível; ele fornece uma solução personalizada que garante um valor maximizado e mensurável a partir de uma estratégia de recuperação civil.

Descrição

• Lead all aspects of data management for medical device clinical trials, ensuring compliance with FDA, MDR, ICH-GCP, and ISO 14155 regulations. • Develop and maintain Data Management Plans (DMPs) and Case Report Forms (CRFs) aligned with study protocols. • Design, validate, and manage Electronic Data Capture (EDC) systems such as Medidata RAVE, Oracle InForm, or Veeva Vault EDC. • Oversee data cleaning, query management, and reconciliation processes to ensure high-quality, analyzable datasets. • Ensure adherence to CDISC/CDASH/SDTM standards, enabling efficient regulatory submission. • Conduct and support data audits, quality control (QC) reviews, and database lock activities. • Serve as the data management lead for multiple studies, collaborating with cross-functional teams including clinical operations, biostatistics, and regulatory affairs. • Manage relationships with CROs, vendors, and external data management teams, ensuring alignment with project timelines and quality standards.

🎯 Requisitos

• Bachelor's or Master's degree in Life Sciences, Clinical Research, Biostatistics, Computer Science, or a related field. • Certified Clinical Data Manager (CCDM) or equivalent certification is a plus. • 5+ years of experience in clinical data management within the medical device industry or related healthcare sectors. • Proven experience in Phase I-IV clinical trials, IDE/PMA/510(k) submissions, or post-market studies. • Strong knowledge of electrophysiology (EP) trials is a plus but not required. • Experience managing EDC systems (e.g., Medidata RAVE, Veeva Vault, Oracle InForm, Medrio). • Familiarity with ISO 14155, CDISC/CDASH/SDTM, and FDA 21 CFR Part 11 compliance. • Knowledge of SQL, SAS, or other clinical data programming tools is beneficial.

🏖️ Benefícios

• This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.