Sr. Clinical Data Manager
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.
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.
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.
Apply tot his job
Apply To this Job
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.
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.
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.
Apply tot his job
Apply To this Job