Sr Manager Clinical Safety

Overview:

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care.

At Cordis, we're teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients.

If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you.

We are the people behind the people who keep saving lives.

Responsibilities:

Cordis Corporation is seeking a Senior Clinical Safety Manager to provide clinical safety leadership for investigational medical device programs, with a primary focus on complex interventional cardiovascular and peripheral device technologies across coronary and peripheral indications.

This role is accountable for end-to-end clinical safety oversight across clinical trials, including adverse event management, safety signal detection, and interface with independent oversight committees. The Senior Clinical Safety Manager will serve as a primary safety point of contact with Data Safety Monitoring Boards (DSMBs) and Clinical Events Committees (CECs), coordinating safety activities and, as appropriate, presenting clinical safety data directly to these bodies. The role partners closely with Clinical Affairs, Medical Affairs, Risk Management, Quality/Complaints, and Regulatory teams to ensure patient safety, regulatory compliance, and high-quality evidence generation.

Key Responsibilities

- Provide end-to-end clinical safety oversight for assigned peripheral and coronary clinical trials, maintaining continuous awareness of the evolving safety profile of assigned products.

- Serve as the clinical safety subject matter expert for ongoing studies, providing guidance to Clinical, Medical, and Program leadership.

- Oversee the intake, assessment, medical review, and classification of AEs, SAEs, and device deficiencies arising from clinical trials.

- Ensure accurate determination of seriousness, severity, expectedness, and causality in collaboration with medical reviewers.

- Ensure timely, complete, and compliant safety reporting to regulatory authorities, ethics committees, and other required stakeholders.

- Support reconciliation and alignment between clinical safety data and complaint handling systems.

- Conduct ongoing safety surveillance and trend analysis across clinical trial data.

- Identify emerging safety signals and proactively escalate risks to cross-functional stakeholders.

- Support safety reviews, internal governance forums, and benefit-risk assessments as required.

- Serve as the primary clinical safety interface with DSMBs and CECs for assigned studies.

- Coordinate the preparation, review, and delivery of safety data packages, narratives, and analyses for DSMB and CEC review.

- Present clinical safety data directly to DSMBs and CECs, as appropriate, and respond to committee questions with scientific rigor and transparency, including in coordination with CROs.

- Oversee accurate and timely clinical event adjudication through the CEC process.

- Track, document, and ensure appropriate internal escalation and implementation of DSMB and CEC recommendations.

- Maintain appropriate governance, confidentiality, and independence in all interactions with oversight committees.

- Partner with Quality and Complaints teams to cross-reference clinical AEs with post-market complaint data and identify overlapping or emerging safety signals.

- Collaborate with Risk Management to inform and update Risk Management Files (RMF) and support hazard identification, risk evaluation, and mitigation strategies.

- Ensure alignment between clinical safety findings and overall product risk assessments.

- Contribute clinical safety content to Clinical Investigation Plans, Investigator’s Brochures, Clinical Study Reports, and regulatory submissions and responses.

- Support health authority interactions, audits, and inspections related to clinical safety.

- Ensure clinical safety documentation is complete, accurate, and inspection-ready.

- Work closely with Clinical Operations, Medical Affairs, Biostatistics, Data Management, Quality, and Regulatory Affairs.

- Communicate safety trends, risks, and recommendations clearly to internal stakeholders and leadership.

- Act as a central safety liaison between independent oversight committees and internal Cordis teams.

- Contribute to the development and continuous improvement of clinical safety processes, SOPs, and work instructions.

- Identify opportunities to improve safety workflows, data quality, and cross-functional integration.

Qualifications:

Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Medicine, Biomedical Engineering, or a related field required.

6+ years of experience in clinical safety, clinical development, or medical monitoring within medical devices or interventional cardiovascular/vascular technologies.

Preferred Qualifications:

• Advanced degree (Master’s, PharmD, MD, or equivalent) preferred.
• Demonstrated hands-on experience managing AEs and SAEs in clinical trials.
• Direct experience interfacing with DSMBs and/or CECs, including preparation of safety packages and participation in committee meetings.
• Experience in peripheral and/or coronary devices, large bore access, IVL, or related technologies strongly preferred.
• Strong understanding of clinical safety principles and regulatory expectations for investigational medical devices.
• Ability to interpret complex clinical data and assess safety trends.
• High scientific credibility and confidence presenting to independent oversight committees.
• Excellent written and verbal communication skills.
• Strong judgment, attention to detail, and ability to operate effectively in high-visibility, high-accountability situations.
• Strategic thinker with strong execution focus
• Excellent leadership and stakeholder management skills
• Ability to operate effectively in a fast-paced, growth-stage environment
• Strong written and verbal communication skills
• Data-driven decision-making and problem-solving mindset

Up to 25–40% travel , including site visits, investigator meetings, and scientific conferences

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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.