Cordis · 15 hours ago
Senior Manager, Clinical Study Management (Remote)
United States
Full-time
Remote
Senior Level, Lead/Staff
12+ years expCordis is a global leader in cardiovascular and endovascular technology, dedicated to saving lives and transforming cardiovascular care. The Senior Manager, Clinical Study Management will oversee a high-priority peripheral IDE study, leading day-to-day operations and collaborating with cross-functional teams to ensure successful execution and compliance with regulations.
Health CareHealth DiagnosticsMedical
Responsibilities
Oversee all aspects of clinical trials to ensure trials are executed and completed on time, and in compliance with SOPs, Regional regulatory regulations and ICH/GCP guidelines, with minimal supervision
Has oversight of all operational activities including but not limited to development of clinical study design/protocol , vendor selection and ensure all aspects of trial execution through close-out is successfully completed in accordance to SOPs and regulatory compliance
Lead and oversee organization and content preparation for key meetings with investigators and study coordinators, training, etc
Leads and coordinates trial team activities in compliance with SOPs, other procedural documents and applicable regulations
Leads project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting
Collaborate with the CRO, Bio Stats and additional vendors, ensuring the deliverables are of the highest quality
Serve as a key clinical interface with cross functional teams to clearly articulate the medical rational and data analysis as applicable
Establish relationships with opinion leaders, prominent academic and clinical investigators and leaders of medical and scientific organizations and assist with supporting relevant medical queries on protocol and /or related study operational aspects
Prepare and present dashboards, reports, and other tracking mechanisms to provide insight into the study's progress in collaboration with CRO as needed and providing to manager(s) for leadership updates
Organize and support leading Steering Committee events, ensuring that the objectives are clearly communicated and achieved. Oversee content preparation for these meetings
Ensures accurate tracking and timely reporting/escalations to proactively mitigate foreseeable risks
Actively contributes to process improvement; training and mentoring of Clinical team
Lead data aspects of Clinical study report, and possibly support podium /publication initiatives
Qualification
Required
University degree or the equivalent combination of education and experience required
Requires a total minimum of 12+ years of relevant experience
Experience with IDE trials is required
Understanding of clinical trial processes (e.g., data management, safety reporting, biostatistics, medical writing) and experience in driving execution, from study start-up through study closure
Understanding of clinical trial design principles, regulations and statistical rationale
Understanding of patient care cardiovascular and peripheral vascular procedures (especially Drug Coated balloon technologies)
Strong interpersonal skills and ability to foster deep business relationships with stakeholders
Capable of clear and concise provision of live teaching of complex scientific concepts to both medical and non-medical personnel
Clinical and working knowledge of peripheral arterial disease required
Ability to quickly learn about disease states and therapeutic options to guide business development and pipeline development opportunities
Able to balance multiple priorities and multi-task as well as follow escalation pathways
Strong analytical and problem solving skills and strategic thinking
Capability to work in a smaller and flatter organizational structure, requiring diverse responsibilities with high visibility and access to Sr. Management
Ability to work effectively in a fast-paced and ever-changing environment
Awareness of clinical guidelines (e.g., ACC/AHA, ESC, TASC)
Proficiency in analyzing and discussing statistical concepts such as Kaplan-Meier survival curves, Hazard ratios and confidence intervals
Proven ability to develop relationships with physicians and other Healthcare Professionals
Preferred
A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required, Masters or a Medical degree optional
A minimum of 6 years of Clinical Study Management experience at a Sponsor or CRO, preferably in cardiovascular and peripheral therapy areas
Strong knowledge of drug-eluting technologies, vascular biology, and clinical trial methodology(preferred)
Company
Cordis
Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
1001-5000 employees
H1B Sponsorship
Cordis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (3)
2023 (3)
2022 (4)
Funding
Current Stage
Late StageTotal Funding
unknown2021-03-12Acquired
Leadership Team
Scott Drake
Chief Executive Officer
Recent News
2025-11-11
TeamBest Global Companies
2025-11-07
News-Medical.Net
2025-11-01
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