Clinical Data Manager

WHO WE ARE

We are a growing medical device company developing innovative technology to transform the treatment of mitral valve disease. Our team is advancing a transcatheter mitral valve replacement through pivotal clinical development, with a shared commitment to bringing safe, effective, and innovative technology to patients.

THE OPPORTUNITY

We are seeking a Clinical Data Manager to support the execution of clinical data management activities for our investigational structural heart device studies. Working closely with the Principal Data Manager and cross-functional partners, you will help ensure clinical trial data is accurate, complete, reliable, and ready to support critical study milestones and regulatory submissions.

This is an opportunity to take ownership of day-to-day data management activities across the clinical trial lifecycle, from study start-up and database development through data cleaning, database lock, and regulatory submission. Your work will directly support the quality and integrity of the clinical evidence needed to advance our technology toward commercialization.

HOW YOU WILL CONTRIBUTE

• Manage day-to-day clinical data activities for assigned studies, ensuring alignment with study protocols, Data Management Plans, regulatory requirements, and company procedures.
• Support the development and maintenance of clinical databases, electronic Case Report Forms (eCRFs), data management documentation, and related guidelines.
• Perform data cleaning, query management, data validation, reconciliation, and quality control to ensure accurate, complete, and consistent clinical trial data.
• Monitor data quality, outstanding queries, discrepancies, and study timelines, proactively communicating risks and escalating issues as needed.
• Support database lock preparation and execution, including data cleaning, reconciliation, documentation review, and resolution of outstanding issues.
• Collaborate with Clinical Operations, Biostatistics, Regulatory Affairs, Clinical Affairs, clinical research sites, and external vendors to support timely data collection, review, and delivery.
• Support electronic data capture (EDC) system activities, including user acceptance testing, troubleshooting, and coordination with system vendors.
• Prepare and review clinical data listings, reports, data transfers, and other deliverables supporting clinical study reports and regulatory submissions.
• Maintain accurate, traceable, audit-ready documentation and support internal audits, regulatory inspections, and quality reviews.
• Support compliance with applicable FDA regulations, 21 CFR Part 11, ICH-GCP, ISO 14155, EU MDR, and relevant clinical data standards.
• Identify opportunities to improve data management processes, strengthen data quality, and promote consistency across clinical studies.

WHY JOIN US

• Make an impact: Help ensure the integrity of clinical evidence supporting an innovative technology designed to improve patient care.
• Contribute to pivotal research: Support clinical trials that are critical to advancing a Class III structural heart device toward regulatory approval.
• Own meaningful work: Manage key data management activities and contribute across the clinical trial lifecycle.
• Collaborate across disciplines: Partner with experienced professionals across Clinical Operations, Biostatistics, Regulatory, Clinical Affairs, and external research partners.
• Grow your expertise: Build experience with complex clinical studies, regulatory submissions, EDC systems, and evolving clinical data management practices.
• Help shape the process: Join a growing organization where initiative, problem-solving, and continuous improvement make a meaningful difference.