Senior Clinical Data Manager

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🕒 March 18

🏈 Alabama – Remote

🏈 Alabama – Remote

⏰ Full Time

🟠 Senior

📊 Data Scientist

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CRS

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11 - 50 employees

Civil Recovery Solutions Limited (CRS) offer the next generation in specialist civil recovery and civil litigation services. CRS combines a team of highly experienced personnel with powerful new technology and bespoke tools to manage the civil recovery process extremely effectively and efficiently. The easily integrated CRS model is radically different and flexible; it provides a tailored solution ensuring maximised and measurable value from a civil recovery strategy.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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.