Senior Manager, Clinical Study Management (Remote)
About The Position
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.
Requirements
- University degree or the equivalent combination of education and experience required.
- Requires a total minimum of 12+ years of relevant experience.
Nice To Haves
- Advanced/graduate degree preferred for some disciplines.
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
