Clinical Monitoring Lead

2 weeks ago

New York, New York, United States Cordis Full time

Overview

Cordis is at the forefront of medical technology, focusing on innovative solutions for cardiovascular and peripheral vascular conditions. Our leading product, SELUTION, integrates pharmaceuticals with a conventional balloon catheter, transforming the treatment landscape for coronary and peripheral artery diseases. With multiple Investigational Device Exemptions (IDEs) approved and actively enrolling participants, Cordis is committed to advancing patient care through cutting-edge medical solutions.

Role Summary

The Clinical Monitoring Manager will play a crucial role in establishing an internal Clinical Research Associate (CRA) team to support a comprehensive clinical program. This position is vital to Cordis's mission to enhance patient outcomes and will directly contribute to the organization's success. The Clinical Monitoring Manager will develop the framework for in-house monitoring and recruit a team of skilled CRAs. This role will focus on monitoring timelines and ensuring adequate coverage across all clinical studies.

Key Responsibilities

  • Develop and implement processes and protocols related to clinical monitoring.
  • Recruit and supervise a team of experienced CRAs, fostering their professional growth.
  • Facilitate cross-functional communication and planning for monitoring activities associated with each clinical IDE.
  • Oversee the tracking and execution of monitoring plans in alignment with PMA submission timelines.
  • Allocate resources effectively across studies and regions.
  • Provide oversight for globally outsourced CRO monitoring activities.
  • Assist in preparing for BIMO audit readiness concerning IDE trial monitoring.
  • Communicate project plans, progress, achievements, and lessons learned to leadership, given the high visibility of these initiatives.
  • Address and escalate issues as necessary.
  • Ensure the quality of CRA documentation through thorough review and guidance.
  • Travel as required for remote or on-site visits.
  • Maintain knowledge of and ensure compliance with relevant ICH Guidelines, Good Clinical Practices, ISO 14155, and Regulatory Agency requirements.

Key Interactions

This role will involve significant interaction with leadership, study managers, healthcare professionals, 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 in approach.
  • Proven leadership skills with the ability to inspire and support a team.
  • Strong remote team management capabilities.
  • Excellent communication skills.
  • Supportive and committed to promoting quality through example and ongoing support.
  • Global perspective with international orientation.
  • Ability to make independent decisions.
  • Strong prioritization skills to meet deadlines.
  • Ability to work across multiple time zones.
  • Fluency in English is required.

Why Choose Cordis?

For over six decades, Cordis has been dedicated to developing interventional vascular technologies that enhance quality and provide less invasive solutions for patients worldwide. With a global presence and extensive resources, we empower our employees to excel and reach their full potential. We are committed to fostering a diverse and inclusive workplace where all team members feel valued and supported.

Cordis is an equal opportunity employer, and we celebrate diversity in all its forms. We strive to create an inclusive environment where every individual’s perspective contributes to our success.

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