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| Company Name: |
Radiometer |
| Location: |
New Brighton, MN United States |
| Position Type: |
Full Time |
| Post Date: |
12/09/2024 |
| Expire Date: |
02/09/2025 |
| Job Categories: |
Healthcare, Other |
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Senior Manager, Clinical Affairs US
The Sr. Clinical Affairs Manager is responsible for directly managing a team driving clinician studies execution and will play a critical role in the timely, effective, and quality completion of clinical studies. This position is responsible for systematic and organized clinical operations, metrics and KPIs, financial forecasting and budget reconciliation.
This position is part of the Clinical & Medical Affairs department, of which the EU Hub is located in Brønshøj (Denmark) and the US Hub in Minneapolis.
This position will report to the Director of Clinical Affairs in the US and will be based in New Brighton, MN, in an on-site role.
At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. If you thrive in an amazing, multifunctional, fast-paced role and want to work to build a world-class clinical affairs organization—read on.
In this role, you will have the opportunity to:
- Manage a team of Site Managers/CRAs, Clinical Study Managers, and Clinical Trial Assistants (as applicable), assigned to study execution, site management, and administration of clinical trials. This involves active mentoring, regular coaching, and developing people to build skills and elevate capabilities
- Form strong relationships with key Investigators and coordinators, driving high clinical site engagement (e.g., newsletters, video meetings)
- Accountable to ensure the team is trained and follows the currently approved protocol/amendment(s), SOPs, GCP, PHI, and applicable regulatory requirements
- Drive clinical schedule deliverables and project financial forecasts to meet the overall project timelines, influencing internal and external partners to support on-time delivery through relationship management skills
- Responsible for executing a well-controlled operation to manage sample chain-of-custody and investigational product reconciliation
- Drive highly organized, coordinated reviews of metrics and KPI (e.g., cycle times, query age, SDV rate, deviation trending)
- Manage and frequently analyze data to track progress and assign clear actions
Qualifications & Requirements
- Bachelor’s Degree in field with 9+ years of clinical research experience in Medical Device, In-Vitro Diagnostic, or a related field, 7+ years of experience with Master’s Degree, or 4+ years of experience with a PhD degree.
- Minimum of 2 years of directly leading a team and managing people
- Knowledge and experience with GCP and global medical device / IVD regulations
- Operational excellence mindset, detailed-oriented, critical thinker, and problem-solver
- Excellent organizational skills, written and oral communication skills, as well as capabilities in effective conflict management
- Collaborative yet can work independently while thriving in a dynamic and fast-paced environment
Able to travel for business up to 35%
It would be a plus if you also possess previous experience in:
- Leading a complex multicenter enrollment study with interactions with regulatory bodies
- Technical or medical knowledge of cardiac or heart failure disease
- Partnering with Data Management to build eCRF, EDC, and study management reports
- Actively participated in either internal or external study audits
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| Contact Name: | Patina Jackson |
| Company Name: |
Radiometer |
| Phone Number: | 4699536049 |
| Contact Email: | patina.jackson@danaher.com |
| Website: | https://danaher.wd1.myworkdayjobs.com/RadiometerJobs/job/New-Brighton-Minnesota-United-States/Senior-Manager--Clinical-Affairs-US_R1272546 |
Company Description:
In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating impactful innovations like ours, doesn’t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.
Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
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