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Role Description

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.

• 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.
• Work closely with electrophysiology (EP) experts, principal investigators, and clinical research teams to ensure accurate data collection and interpretation.
• Provide mentorship and guidance to junior data managers and other team members.
• Manage relationships with CROs, vendors, and external data management teams, ensuring alignment with project timelines and quality standards.
• Ensure compliance with FDA 21 CFR Part 11, ICH-GCP, ISO 14155 (for medical devices), and MDR regulations.
• Support regulatory submissions (e.g., PMA, 510(k), CE Mark, IDE) by ensuring proper data documentation and formatting.
• Participate in audits and inspections by regulatory bodies and implement corrective actions as needed.
• Stay updated on evolving medical device data management best practices and regulatory requirements.
• Generate and review clinical study reports, data listings, and reconciliation outputs.
• Support statistical programming and data analysis in collaboration with biostatistics teams.
• Ensure seamless data integration with clinical trial management systems (CTMS) and safety databases.

Qualifications

• 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.

Requirements

• Strong leadership, problem-solving, and analytical abilities.
• Excellent attention to detail and ability to manage multiple clinical studies simultaneously.
• Strong communication and collaboration skills for working with clinical, regulatory, and biostatistics teams.
• Ability to work effectively with CROs, vendors, and external stakeholders.

Location and Travel Requirements

• This is a fully remote position and may be performed anywhere within the United States of America.
• Occasional domestic travel may be required for company meetings, audits, etc.