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.

WHAT YOU NEED TO SUCCEED (MINIMUM QUALIFICATIONS)

• Bachelor’s or Master’s degree in Life Sciences, Clinical Research, Statistics, Computer Science, or a related technical field.
• 3–6 years of experience in clinical data management, preferably within the medical device industry.
• Experience supporting clinical trials across the data management lifecycle, including database development, data cleaning, query management, and database lock.
• Working proficiency with Electronic Data Capture (EDC) systems, such as Medidata Rave or CatchTrials, and familiarity with CRF/eCRF design.
• Knowledge of clinical data validation, reconciliation, quality control, and data integrity requirements.
• Familiarity with applicable clinical research regulations and standards, including ICH-GCP, FDA 21 CFR Part 11, and ISO 14155.
• Strong analytical, organizational, and problem-solving skills, with excellent attention to detail.
• Effective written and verbal communication skills and the ability to collaborate across functional teams.
• Ability to manage multiple priorities, meet deadlines, work independently, and recognize when issues require escalation.

WHAT WILL SET YOU APART (COMPETENCIES)

• Structural Heart & Medical Device Experience: Experience supporting investigational medical device trials, particularly structural heart or other Class III devices.
• Regulatory Submission Experience: Familiarity with IDE, PMA, 510(k), CE Mark, or post-market clinical study requirements.
• Clinical Data Standards: Knowledge of CDISC, CDASH, and SDTM standards and their application to clinical trial data.
• Advanced Data Skills: Familiarity with SQL, SAS, or other clinical data reporting and analysis tools.
• EDC & Database Expertise: Experience configuring, maintaining, testing, or troubleshooting clinical databases and electronic data capture systems.
• Vendor & Site Collaboration: Experience coordinating data deliverables, resolving discrepancies, and maintaining data quality with clinical research sites, CROs, and external vendors.
• Regulatory & Data Privacy Knowledge: Familiarity with data protection requirements, including GDPR where applicable.
• Ownership & Accountability: Takes initiative, follows through on commitments, and proactively addresses data quality issues.
• Adaptability & Continuous Improvement: Comfortable managing competing priorities in a fast-paced environment while identifying opportunities to improve processes and outcomes.
• Relevant Credentials: Clinical data management or industry certifications, such as CCDM or CDISC-related credentials, are a plus.