Senior Clinical Study Manager

Cordis•Irvine, CA

2d•$139,700 - $200,200•Remote

About The Position

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. The Senior Clinical Study Manager (Sr. CSM) will provide leadership, direction, and oversight for a complex, multi-center patient registry within the MedAlliance LLC / Cordis SelutionSLR portfolio. This role manages study/registry 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/registry stakeholders, ensuring timelines, budgets, and quality objectives are met in support of clinical and regulatory milestones.

Requirements

Bachelor’s degree in Life Sciences, Nursing, or related field (or equivalent ed. & exp.).
Minimum 12+ years of clinical research experience with at least 5 years in registry mgmt.
Strong understanding of GCP, ISO 14155, GDPR, and FDA/EMA device regulations.
Proven experience leading complex, multicenter patient registries.
Excellent organizational, leadership, and cross-functional communication skills.
Understanding 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

Nice To Haves

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

Responsibilities

Lead the planning, initiation, and management of assigned registry duties across multiple regions.
Develop and maintain project plans, risk management strategies, and timelines to ensure registry deliverables are achieved, following timely escalation pathways.
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.
Track registry 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 registry protocols, CRFs, and statistical analysis plans.
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.