Senior Clinical Study Manager; Global Patient Registries - Remote

Overview

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Remote-based on the U.S. East Coast or in the EU. The Senior Clinical Study Manager (Global Patient Registries) will provide leadership, direction, and oversight for a complex, global patient registries within the Med Alliance LLC / Cordis Selution

SLR portfolio. This role manages study/global patient registries team functions and external vendors to ensure successful execution of clinical trials from initiation through close-out, maintaining compliance with GCP, ISO 14155, GDPR, and all applicable regulatory requirements. The Sr. CSM serves as a key point of contact for global study/global patient registries stakeholders, ensuring timelines, budgets, and quality objectives are met in support of clinical and regulatory milestones.

• Lead the planning, initiation, and management of assigned global patient registries duties across multiple regions.
• To ensure that global patient registries deliverables are achieved, you will develop and maintain project plans, risk management strategies, and timelines, following timely escalation pathways.
• Track global patient registries metrics and provide dashboards in collaboration with the CRO.
• Lead cross-functional global registry team meetings and maintain strong communication among stakeholders.
• Support the development and review of global patient registries protocols, CRFs, and statistical analysis plans.
• Oversee vendor selection, contract negotiations, and ongoing performance management (CROs, Biostats, etc.).
• Support management of budgets, forecasts, and financial reconciliation processes.
• Ensure the preparation, review, and maintenance of essential documents and regulatory submissions in coordination with the CRO.
• Oversee site feasibility, selection, initiation, monitoring, and close-out activities in collaboration with CRAs and Field Research Specialists in coordination with the CRO.
• Ensure the Sponsor / CRO are inspection-ready and compliant with internal and external standards.
• Clinical Data Handling to assist with abstracts, manuscripts, etc., for conference and publication submissions
• Contribute to continuous improvement initiatives and global clinical operations best practices, including mentorship and coaching of junior team members.

Required Qualifications:

• Candidates should be located on the U.S. East Coast (EST) or in the European Union.
• 5+ years’ proven experience leading complex, global patient registries.
• Minimum 12+ years of clinical research experience.
• Strong understanding of GCP, ISO 14155, GDPR, and FDA/EMA device regulations.
• Bachelor’s degree in Life Sciences, Nursing, or related field (or equivalent ed. & exp.).
• Must possess strong English communication skills. Multi-lingual skills are highly desirable.
• Excellent organizational, leadership, and cross-functional communication skills.

• Experience with cardiovascular (Coronary is a plus) studies & PMA activities
• Familiarity with global regulatory requirements and submissions.
• Proficiency with eTMF, CTMS, and data management systems (EDC).
• Exposure to medical writing procedures and practices

• Understanding global patient registries, medical terminology, and data interpretation/outputs.
• Excellent decision-making, conflict resolution / problem-solving skills.
• Financial and resource management acumen.
• Accountability, adaptability, flexibility and results orientation with ability to operate with autonomy, balance multiple priorities, multi-task and escalate key challenges

• Remote work environment with occasional travel for site visits, audits, or meetings.
• Must comply with all company, regulatory, and EHS standards.

The expected pre-tax pay rate for this position is $139,700 - $200,200 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

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 teammates’ 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.