Role Description
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Participate in reading ECGs, Holters, Patch and stress test data, as well as blood pressure variability assessments and other relevant endpoints to generate endpoint data for our customers.
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Contribute to ECG and Blood Pressure core lab procedures to maintain and improve ECG interpretation and other data consistency and efficiency.
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Review cardiology edit checks and participate in Cardiologist QA program.
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Participate in assigning cardiologists to Expert protocols or consulting projects, as needed.
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Oversee the training and QA of subcontractor (external) cardiologists.
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Represent Clario in providing scientific expertise and assistance to pharmaceutical sponsors across a range of consulting services encompassing protocol design/development elements related to Cardiac Solutions+ offerings, statistical analysis plans, expert report writing and regulatory representation.
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Represent Clario in discussions with clients concerning prospective or ongoing work across therapeutic areas where Cardiac Solutions+ (Safety or efficacy) strategies are needed as well as other expanded digital endpoints.
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Interface with other departments regarding cardiology issues, cardiologist activities, cardiac solutions and safety consulting, and cardiac related compliance strategies.
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Support the clinical consulting for other Digital Physiology and Clario endpoints for cross business unit opportunities and therapeutic area strategies.
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Assist the Cardiac Solutions Scientific and Medical Affairs leadership in developing and maintaining policies and procedures for Cardiac Solutions+, including Cardiology Review Guidelines, Cardiology Review SOPs and other matters relating to Cardiology and other digital physiology expanded endpoints.
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Keep abreast of the latest scientific developments in cardiac safety & efficacy and educate internal stakeholders on such developments/advances as appropriate.
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Work with the Sales team to provide sales support as needed.
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Assist Clario Product Management & Development with development and validation of EXPERT and other Clario systems as well as the evaluation of 3rd party medical devices.
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Support Clario in meetings and research collaborations with regulatory authorities.
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Assist in statistical innovation and research, support sponsor interactions involving statistical design and analysis considerations, strategic contribution at the Clario level liaising across all lines of business to maximize value and utilization of Digital Physiologyβs statistical capabilities.
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Oversee other contract resources as assigned.
Qualifications
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MD degree is mandatory.
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Clinical Cardiac Electrophysiology training is preferred.
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Minimum of 3 years in pharmaceutical industry as an employed cardiologist or consultant in early phase development.
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Experience with and knowledge of cardiac safety and efficacy in clinical trials is strongly preferred.
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ABIM Board certification in Cardiovascular Diseases for US based candidates.
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Minimum of 5 years clinical cardiology and electrocardiography experience preferred.
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A preferred candidate also has experience with concentration effect modeling and strong familiarity with the ICH E14 guidance.
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Experience with writing reports for QT waivers and a functional knowledge of clinical pharmacology is desirable.
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Experience in working with and/or consulting for pharmaceutical industry Sponsors.
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High ethical standards with commitment to represent Clario to the highest standards.
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Team player, communicative, business oriented.
Requirements
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The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.
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This JOB description should not be deemed all-inclusive. Additional requirements and expectations may be assigned.
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At all times, employees are expected to adhere to company policies and company SOPs.
EEO Statement
Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.