Clinical Monitoring Lead

2 weeks ago

New York, New York, United States Cordis Full time

Overview

Cordis is at the forefront of medical technology, dedicated to innovative solutions for cardiovascular and peripheral vascular conditions. Our premier product, SELUTION, merges pharmaceuticals with a conventional balloon catheter, transforming the treatment landscape for coronary and peripheral artery ailments. With multiple Investigational Device Exemptions (IDEs) currently active and enrolling participants, Cordis is committed to advancing impactful medical solutions.

Role Summary

The Clinical Monitoring Lead will play a pivotal role in establishing an internal Clinical Research Associate (CRA) team to support a comprehensive clinical initiative. This research is a top priority for Cordis, and this position will significantly contribute to enhancing patient care. The Clinical Monitoring Lead will develop the framework for in-house monitoring and recruit a team of skilled CRAs. This role will focus on tracking timelines and ensuring adequate monitoring coverage across all studies. The Clinical Monitoring Lead will engage extensively with the clinical team, cross-functional internal teams, clinical vendors, and healthcare professionals.

Key Responsibilities

  • Develop and implement processes and protocols related to clinical monitoring.
  • Recruit and oversee a team of proficient CRAs, providing guidance and development.
  • Facilitate cross-functional communication and planning concerning monitoring for each clinical IDE.
  • Monitor and execute plans aligned with PMA submission timelines for each study.
  • Allocate resources effectively across studies and regions.
  • Oversee global CRO monitoring efforts.
  • Assist in BIMO audit readiness planning concerning IDE trial monitoring.
  • Communicate project plans, statuses, achievements, and lessons learned to leadership.
  • Address issues as they arise.
  • Ensure the quality of CRA documentation through thorough review and mentorship.
  • Travel as required, which may include remote or on-site visits.
  • Maintain compliance with relevant ICH Guidelines, Good Clinical Practices, ISO 14155, and Regulatory Agency requirements.

Key Interactions

Engage with leadership, study managers, physicians, site personnel, CROs, and external vendors.

Qualifications

  • Minimum of 5 years of experience managing CRAs and monitoring programs both in the US and internationally.
  • At least 5 years of monitoring experience.
  • In-depth knowledge of the medical device industry and cardiovascular sector.
  • Detail-oriented, precise, and rigorous.
  • Proven leadership skills with the ability to inspire and support a team.
  • Strong management capabilities for remote teams.
  • Excellent communication skills.
  • Supportive and committed to promoting quality through example and continuous assistance.
  • Global perspective with international orientation.
  • Ability to make independent decisions.
  • Skilled in prioritizing tasks to meet deadlines.
  • Able to work across multiple time zones.
  • Fluency in English is required.

Why Choose Cordis?

For over six decades, we have been advancing interventional vascular technology that enhances quality and minimizes invasiveness for individuals worldwide. With a global presence and extensive resources, we empower our employees to excel and realize their full potential. We value diversity and inclusion, recognizing that different perspectives contribute to our success. Together, we strive to create an equitable and welcoming environment for all.

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