Cordis · 16 hours ago
Senior Clinical Study Manager
Irvine, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$140K/yr - $200K/yr
12+ years expCordis, in partnership with Selution, specializes in the development of innovative technology for advanced drug device combination products. The Senior Clinical Study Manager will lead and oversee a complex, multi-center patient registry, ensuring compliance with regulatory requirements and successful execution of clinical trials.
Health CareHealth DiagnosticsMedical
No H1B
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
Qualification
Required
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
Preferred
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
US work authorization is a precondition of employment
Company
Cordis
Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2021-03-12Acquired
Leadership Team
Scott Drake
Chief Executive Officer
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