Sr. Clinical Data Manager

Role Overview

We are seeking an experienced Sr. Clinical Data Manager to lead and oversee data management activities for medical device clinical trials, with a focus on Electrophysiology (EP). This role involves ensuring high-quality, regulatory-compliant data collection and analysis to support clinical trials from start-up to submission.

What You Will Do

Lead all aspects of data management for medical device clinical trials, develop and maintain Data Management Plans (DMPs) and Case Report Forms (CRFs), design, validate, and manage Electronic Data Capture (EDC) systems, oversee data cleaning, query management, and reconciliation processes, and ensure adherence to CDISC/CDASH/SDTM standards.

Why It Might Be a Fit

The ideal candidate will have expertise in clinical data management, regulatory compliance, and database development, with a strong understanding of clinical trial processes in the medical device industry. Experience in Electrophysiology (EP) trials is a plus but not mandatory.

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

• E-Verify participation