Heart Rhythm Clinical Research Solutions · 8 hours ago
Sr. Clinical Data Manager
United States
Full-time
Remote
Senior Level
5+ years expHeart Rhythm Clinical Research Solutions is a full-service CRO focused on transforming data into evidence for better care. The Sr. Clinical Data Manager will lead data management activities for medical device clinical trials, ensuring high-quality and regulatory-compliant data collection and analysis.
Health CareMedicalMedical Device
Responsibilities
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
Qualification
Required
Bachelor's or Master's degree in Life Sciences, Clinical Research, Biostatistics, Computer Science, or a related field
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
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
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
Preferred
Experience in Electrophysiology (EP) trials is a plus but not mandatory
Certified Clinical Data Manager (CCDM) or equivalent certification is a plus
Strong knowledge of electrophysiology (EP) trials is a plus but not required
Knowledge of SQL, SAS, or other clinical data programming tools is beneficial
Company
Heart Rhythm Clinical Research Solutions
Improving patients' lives by facilitating high quality clinical research through a collaborative network of physicians.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Jose Osorio
Founder and President
Company data provided by crunchbase