About the role
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.
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.
What you'll do
Clinical Data Management & Oversight
- 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.
Project & Team Leadership
- 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.
Regulatory Compliance & Quality Assurance
- 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.
Data Reporting & Analysis
- 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
Education & Certifications
- 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.
Experience
- 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.
Skills & Competencies
- 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.