Monitoring Manager, Selution (Remote)

Overview
Cordis is a pioneering medical technology company specializing in groundbreaking solutions for cardiovascular and peripheral vascular diseases. Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, Coronary De Novo, Peripheral SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions.
The Monitoring Manager will help build an in-house CRA team to support an extensive clinical program. This research is the top priority for Cordis, and this role will be directly involved in the success of the organization in improving patient care. The Monitoring Manager will build the infrastructure for in-house monitoring and hire a team of experienced CRAs. This role will be heavily involved in tracking of timelines and ensuring the monitoring coverage is sufficient across all studies. The Monitoring Manager will interact heavily with the clinical team, cross-functional internal teams, clinical vendors and with healthcare professionals.
Responsibilities
? Build processes and procedures related to monitoring
? Establish a team of experienced CRAs, and subsequently supervise and develop CRAs
? Manage cross-functional communication and planning related to monitoring for each of the clinical IDEs
? Tracking and execution of a plan to monitor each of the studies in relation to the PMA submission timelines
? Determine allocation of resources to each of the studies and regions
? Provide oversight of CRO monitoring that is outsourced globally
? Help execute BIMO audit readiness planning in relation to monitoring of the IDE trials
? Due to the high visibility of these projects, effectively communicate the project plan, status, achievements, learnings, etc. to leadership
? Escalate issues as needed
? Ensures quality of the CRA's documentation through review and guidance
? Travel as necessary
? The Monitoring Manager may be involved in remote or on-site visits if needed
? Maintain a working knowledge of, and ensure compliance with, applicable ICH Guidelines, Good Clinical Practices, ISO 14155, Regulatory Agency requirements
Key Interactions
? Key interactions with leadership, study managers, physicians and site personnel, CROs, and outside vendors
Qualifications
? 5+ years of experience in management of CRAs with experience managing a monitoring program US and globally
? 5+ years experience monitoring
? Required knowledge of the medical device field and cardiovascular space
? Precise, Rigorous, Detail-Oriented
? Team Leader, ability to inspire and support a team
? Strong management of a remote team
? Strong communication skills.
? Supportive, keen to promote quality through example and continuous support.
? Global, International Orientation
? Ability to take independent decisions
? Skill in prioritizing workflow to meet deadlines
? Capable of working across multiple time zones including Europe
? Fluent in English
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Why Join Cordis?
For more than 60 years, we have been building interventional vascular technology that offers higher quality and less invasive experiences for people around the world. With a global reach and vast network of resources, we empower you to do your best work and unleash your full potential. Do you want to grow your career surrounded by a supportive team of subject matter experts? Then join us and let's improve the wellbeing of millions, together.
Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one's identity. All our teammate's points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.