Cardiologist
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Job Description
Cardiologist supporting Clario’s digital cardiac safety and efficacy solutions for pharmaceutical sponsors. Reading cardiac data, guiding QA, consulting on trials, and supporting regulatory and product initiatives.
Responsibilities:
- Participate in reading ECGs, Holters, Patch and stress test data, blood pressure variability assessments, and other relevant endpoints to generate endpoint data for customers
- Contribute to ECG and Blood Pressure core lab procedures to maintain and improve ECG interpretation, data consistency, and efficiency
- Review cardiology edit checks and participate in the Cardiologist QA program
- Assign cardiologists to Expert protocols or consulting projects as needed
- Oversee the training and QA of subcontractor cardiologists
- Provide scientific expertise and assistance to pharmaceutical sponsors across consulting services, including protocol design/development, statistical analysis plans, expert report writing, and regulatory representation
- Represent Clario in client discussions concerning Cardiac Solutions+ strategies and expanded digital endpoints
- Interface with other departments regarding cardiology issues, cardiologist activities, cardiac solutions, safety consulting, and compliance strategies
- Support clinical consulting for other Digital Physiology and Clario endpoints and therapeutic area strategies
- Develop and maintain Cardiac Solutions+ policies and procedures, including Cardiology Review Guidelines and SOPs
- Keep abreast of scientific developments in cardiac safety and efficacy and educate internal stakeholders
- Work with Sales to provide sales support
- Assist Product Management and Development with EXPERT and other Clario systems and third-party medical device evaluation
- Support meetings and research collaborations with regulatory authorities
- Assist in statistical innovation and research, sponsor interactions involving statistical design and analysis, and strategic cross-business-unit initiatives
- Oversee other contract resources as assigned
Requirements:
- MD degree is mandatory
- Minimum of 3 years in pharmaceutical industry as an employed cardiologist or consultant in early phase development
- ABIM Board certification in Cardiovascular Diseases for US based candidates
- Experience with and knowledge of cardiac safety and efficacy in clinical trials is strongly preferred
- Clinical Cardiac Electrophysiology training is preferred
- Minimum of 5 years clinical cardiology and electrocardiography experience preferred
- Experience with concentration effect modeling and strong familiarity with the ICH E14 guidance is preferred
- Experience with writing reports for QT waivers and a functional knowledge of clinical pharmacology is desirable
- Experience in working with and/or consulting for pharmaceutical industry Sponsors
- High ethical standards with commitment to represent Clario to the highest standards
- Team player, communicative, business oriented
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